USFDA approves Adlyxin to treat type 2 diabetes

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The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials.

In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo in a cardiovascular outcomes trial. Use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.

Adlyxin should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).

The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Adlyxin and other antidiabetic drugs such as sulfonylurea and/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials of Adlyxin.

The FDA is requiring the following post-marketing studies for Adlyxin:

  • Clinical studies to evaluate dosing, efficacy and safety in pediatric patients.
  • A study evaluating the immunogenicity of lixisenatide.

Adlyxin is manufactured by Sanofi-Aventis U.S. LLC, of Bridgewater, New Jersey.


USFDA asks you – How safe is your Hand Sanitiser?

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The U.S. Food and Drug Administration issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.

Antiseptic rubs are products that are intended to be used by consumers when soap and water are not available, and are left on and not rinsed off with water. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands.

“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”

The CDC advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.

Based on new scientific information and input of outside scientific and medical experts on an independent advisory committee, the agency is requesting additional scientific data to demonstrate that the active ingredients used in consumer antiseptic rubs are generally recognized as safe and effective to reduce bacteria on skin. The agency is requesting manufacturers provide data for three active ingredients — alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride. Since 2009, 90 percent of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient.

The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing these products under the OTC Drug Review to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption.

Since the FDA began review of topical antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, new technology that can detect low levels of antiseptics in the body, and the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use. The proposed rule seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for these consumer antiseptic rub active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.

The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by certain populations, including pregnant women and children, for which topical absorption of the active ingredients may be important. Emerging science also suggests that for some antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and that more information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients.

Today’s action is part of the FDA’s larger, ongoing review of OTC antiseptic active ingredients to ensure these ingredients are safe and effective. The FDA has previously issued proposed rulemakings on consumer antiseptic washes (December 2013) and health care antiseptics (April 2015).

The proposed rule will be available for public comment for 180 days. Concurrently, companies will have one year to submit new data and information, and comments on any new data or information may then be submitted to the docket for an additional 60 days. The FDA will then evaluate the data and comments received in response to this proposal. The FDA’s final determination will be published as a final rule (final monograph).

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USFDA approves Cornea Implant for perfect vision

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U.S. Food and Drug Administration approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.

Presbyopia is the loss of the ability to change the focusing power of the eye, resulting in diminished near vision. The focusing power of the eye decreases in nearly all adults over the course of their lifetime. It usually occurs in the fourth or fifth decade of life due to normal aging. Some people may develop symptoms of presbyopia sooner than others, but nearly everyone will eventually develop symptoms and may require some method of near vision correction. Bifocals and reading glasses are a common correction method. Corneal inlay surgery is an elective option for those who may not want to wear glasses.

“Given the prevalence of presbyopia and the aging of the baby boomer population, the need for near vision correction will likely rise in the coming years,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.”

The Raindrop Near Vision Inlay is a clear device made of a hydrogel material and resembles a tiny contact lens smaller than the eye of a needle. It is indicated for use in patients 41 to 65 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.50 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.

To insert the device, an eye surgeon uses a laser to create a flap in the cornea of the patient’s non-dominant eye, implants the device into the opening, and puts the flap back in place. The inlay provides a steeper surface that can help the eye focus on near objects or print. The natural lens of the eye typically performs this function by changing shape, but in patients with presbyopia the lens becomes hardened and ineffective at focusing on close-up objects, which causes poor near vision. By reshaping the curvature of the cornea, the inlay corrects the refractive error that results in near vision problems.

The safety and effectiveness of the Raindrop Near Vision Inlay were studied in a clinical trial of 373 subjects implanted with the device. Two years after implantation, 92 percent of patients included in the analysis (336 out of 364) were able to see with 20/40 vision or better at near distances with the inlay-implanted eye.

The Raindrop Near Vision Inlay implantation may cause or worsen problems with glare, halos, foreign body sensation and pain. There is a risk of developing infection, inflammation, a new dry eye condition or exacerbation of an existing dry eye condition, retinal detachment, or a decrease in distance vision. The device may cause complications of the cornea, such as corneal scarring, swelling, inflammation, thinning, clouding or melting. The device may cause certain tissue in the eye to grow into the cornea (epithelial ingrowth), causing clouding. Some patients may require a second surgery to remove or replace the inlay.

The Raindrop Near Vision Inlay is not recommended for patients who: have severe dry eye or an active eye infection or inflammation; exhibit signs of corneal disease characterized by general thinning and cone-shaped protrusion in the center of the cornea (keratoconus); have abnormal features of the outer part of the eye (cornea) to be implanted; have certain autoimmune or connective tissue diseases; do not have enough corneal thickness to withstand the procedure; have a recent herpes eye infection or problems resulting from a previous infection or have uncontrolled glaucoma or uncontrolled diabetes.

The Raindrop Near Vision Inlay is manufactured by Revision Optics, Inc. of Lake Forest, California.

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Should Online Pharmacies be regulated by DCGI?

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The Indian Internet Pharmacy Association (IIPA) has urged the Drug Controller General of India (DCGI) constituted sub -committee formed under the chairmanship of Maharashtra Food and Drug Administration (FDA) Commissioner Dr Harshdeep Kamble on online pharmacy to help set up a registry of online pharmacies to ensure clarity on the legitimate players and frame interim guidelines.

In most countries, the legitimate players are given specific operating licenses that are shared with consumers to fight the menace of cross border internet pharmacies. IIPA recommends a similar model for India, and also a crackdown on all illegitimate players, online and offline.

Meanwhile, Maharashtra FDA Commissioner has also maintained that online pharmacies can sell only OTC drugs and not prescription drugs until the guidelines are framed.

IIPA is a group of online pharmacies represented by 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com, SaveOnMedicals and Savemymeds.

IIPA has pinpointed that there are multiple online pharmacies operating from different parts of the world that need to be monitored. This according to them will enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

According to IIPA, online pharmacy is currently governed by Information Technology Act, 2000 and Drugs and Cosmetics Act, 1940.

The Drug Controller General of India had earlier directed all the state/UT drugs controllers to keep a strict watch on online sale of drugs and take action if there is  violation of the Drugs and Cosmetics Act and Rules there under.

Recommendations from all stakeholders are currently being reviewed by the Sub-Committee constituted by the 48th Drug Consultative Committee under the chairmanship of Maharashtra Food and Drug Administration Commissioner to formulate guidelines on the use of information technology in online pharmacy and authorise its legal validity.

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USFDA eyes norms on Chewable Tablets

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US FDA has issued a draft guidance on critical quality attributes that  should be assessed during the development of chewable tablets. The regulatory authority has asked the industry to comment on the same and revert before August end.
The recommendations in this guidance apply mainly to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain chemistry, manufacturing, and controls (CMC) supplements to these applications.
Chewable tablets are an immediate release (IR) oral dosage form intended to be chewed and then swallowed by the patient rather than swallowed whole. They should be designed to have a pleasant taste and be easily chewed and swallowed. These tablets should be safe and easy to use in a diverse patient population, paediatric, adult, or elderly patients, who are unable or unwilling to swallow intact tablets due to the size of the tablet or difficulty with swallowing. The availability of safe, easy-to-use dosage forms is important in clinical practice. Chewable tablets are available for many over-the-counter (OTC) and prescription drug products.
The United States Pharmacopoeia (USP) recognizes and differentiates between two types of chewable tablets:. One is chewed for ease of administration, and the other crushed before swallowing to avoid choking to ensure the release of the active ingredient. The concepts in this guidance are applicable to both types of chewable tablets, said the regulatory authority.

Adverse events for chewable tablets can include gastrointestinal (GI) obstruction resulting from patients swallowing whole or incompletely chewed tablets, as well as tooth damage and denture breakage resulting from excessive tablet hardness. A related potential adverse event that sponsors should also consider is esophageal irritation from chewable tablets.
A review of numerous approved drug product applications for chewable tablets revealed that in certain cases critical quality attributes such as hardness, disintegration, and dissolution were not given as much consideration as may have been warranted. This was evidenced by instances of incomplete monitoring and a wide variation in analytical procedures.
The regulator note has stated that its latest draft guidance describes the critical quality attributes that should be considered when developing chewable tablets and recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product.
A variety of physical characteristics should be considered in the manufacturing process for chewable tablets. An ideal chewable tablet should be: Easy to chew, palatable, of appropriate size and shape and able to disintegrate readily to minimise aspiration and facilitate dissolution.
Critical quality attributes for chewable tablets should include hardness, disintegration, and dissolution, as well as all factors that may influence drug bioavailability and bioequivalence. In addition, careful attention should be given to tablet size, thickness, and friability, as well as taste, which may impact the ability or willingness of a patient to chew the chewable tablet. No single quality characteristic should be considered sufficient to control the performance of a chewable tablet. Instead, the goal should be to develop the proper combination of these attributes to ensure the performance of the chewable tablet for its intended use.
Even during conduct of pivotal clinical studies, information should be collected on whether the chewable tablets swallowed were intact. If the shape and size of chewable tablet posed a choking or bowel obstruction risk and whether water was used to aid swallowing and its volume. The subject’s sensory experience like taste, mouth feel, and aftertaste needs to be reported, stated the regulatory authority.

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