CDSCO Office Order 19-Mar-14

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CSDCO Gazette Notification


FDA approves Impavido to treat tropical disease leishmaniasis

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The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.

Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who live in the tropics and subtropics. Most U.S. patients acquire leishmaniasis overseas.

Impavido is an oral medicine approved to treat the three main types of leishmaniasis: visceral leishmaniasis (affects internal organs), cutaneous leishmaniasis (affects the skin) and mucosal leishmaniasis (affects the nose and throat). It is intended for patients 12 years of age and older. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.

“Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The FDA granted Impavido fast track designation, priority review, and orphan product designation. These designations were granted because the drug demonstrated the potential to fill an unmet medical need in a serious disease or condition, the potential to be a significant improvement in safety or effectiveness in the treatment of a serious disease or condition, and is intended to treat a rare disease, respectively. With this approval, Impavido’s manufacturer, Paladin Therapeutics, is awarded a Tropical Disease Priority Review Voucher under a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

Impavido’s safety and efficacy were evaluated in four clinical trials. A total of 547 patients received Impavido and 183 patients received either a comparator drug or a placebo. Results from these trials demonstrated that Impavido is safe and effective in treating visceral, cutaneous and mucosal leishmaniasis.

The labeling for Impavido includes a boxed warning to alert patients and health care professionals that the drug can cause fetal harm and therefore should not be given to pregnant women. Health care professionals should advise women to use effective contraception during and for five months after Impavido therapy.

The most common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated levels of liver enzymes (transaminases) and creatinine.

Paladin Therapeutics is based in Montreal, Canada.

Source: USFDA Consumer Alerts.

FDA approves first implantable hearing device for adults with a certain kind of hearing loss

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The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.

Sensorineural hearing loss is the most common form of hearing loss and occurs when there is damage to the inner ear (cochlea). It may be caused by aging, heredity, exposure to loud noise, drugs that are toxic to the inner ear (e.g., antibiotics), and certain other illnesses. People with severe or profound sensorineural hearing loss of high-frequency sounds may have difficulty hearing faint sounds, understanding people with higher-pitched voices, hearing certain speech sounds, and, in some cases, hearing high-pitched emergency vehicle sirens or common safety alarms, such as smoke detectors.

Hearing loss greatly impacts the education, employment, and well-being of many Americans,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This device may provide improved speech recognition for people with this kind of hearing loss, who have limited treatment options.”

The Nucleus Hybrid L24 Cochlear Implant System combines the functions of a cochlear implant and a hearing aid. This electronic device consists of an external microphone and speech processor that picks up sounds from the environment and converts them into electrical impulses. The impulses are transmitted to the cochlea through a small bundle of implanted electrodes, creating a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember. The hearing aid portion of the device is inserted into the outer ear canal like a conventional hearing aid, and can amplify sounds in the low-frequency range.

The agency evaluated a clinical study involving 50 individuals with severe to profound high-frequency hearing loss who still had significant levels of low-frequency hearing. The individuals were tested before and after being implanted with the device. A majority of the patients reported statistically significant improvements in word and sentence recognition at six months after activation of the device compared to their baseline pre-implant performance using a conventional hearing aid. The device also underwent non-clinical testing, which included the electrical components, biocompatibility and durability of the device.

Of the 50 individuals participating in the study, 68 percent experienced one or more anticipated adverse events, such as low-frequency hearing loss, tinnitus (ringing in the ear), electrode malfunction and dizziness. Twenty-two developed profound or total low-frequency hearing loss in the implanted ear, six of whom underwent an additional surgery to replace the Nucleus Hybrid L24 Cochlear Implant System with a standard cochlear implant.

While the risk of low-frequency hearing loss is of concern, the FDA determined that the overall benefits of the device outweigh this risk for those who do not benefit from traditional hearing aids. Prospective patients should carefully discuss all benefits and risks of this new device with their physicians. The device is intended for use on one ear only.

The Nucleus Hybrid L24 Cochlear Implant System is manufactured by Cochlear Ltd., headquartered in New South Wales, Australia.

Source: USFDA Consumer Alerts

FDA approves Otezla to treat psoriatic arthritis

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psoriatic arthritis

The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”

The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.

Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.

The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.

In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.

Otezla is manufactured for Celgene Corporation, Summit, N.J.

Source: US FDA Consumer Alerts

Merck’s insulin pen, VetPen for use in diabetic dogs and cats receives US FDA nod

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Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck, announced that the US Food and Drug Administration (FDA) has recently approved VetPen, the first insulin pen for use in diabetic dogs and cats. For years, insulin pens have made managing diabetes more convenient for human diabetics. Merck Animal Health, a leader in pet diabetes management, has now brought the same technology to veterinary medicine. VetPen is used with Vetsulin (porcine insulin zinc suspension) insulin cartridges. Vetsulin is the only veterinary insulin product approved for use in both dogs and cats.

“VetPen was developed to make giving insulin injections more convenient for pet owners, and precision dosing makes it easier to consistently deliver an accurate dose of insulin compared to syringes,” said Kathleen Heaney, D.V.M., director of technical services for Merck Animal Health. “VetPen initially will be offered in a number of veterinary clinics throughout the country. This will provide us with the opportunity to work with veterinarians on its use – helping to ensure pet owners are administering Vetsulin safely and effectively.”

Vetsulin is the world’s most trusted veterinary insulin, proven safe and effective for more than 20 years in hundreds of thousands of diabetic pets. Recent advances have made treating diabetes in dogs and cats easier. Today, along with proper diet and exercise, Vetsulin and VetPen play an important role in successfully managing diabetes in both dogs and cats.

“At Merck Animal Health, we are committed to providing veterinarians and pet owners with innovative products to meet the ever changing healthcare needs of animals,” Dr. Heaney said. “VetPen is an exciting breakthrough, which will help in the treatment of pet diabetes – a serious and growing issue in dogs and cats.”

The prevalence of diabetes mellitus in dogs and cats ranges from one in 1001 to one in 5002, and the number of dogs diagnosed with the disease has tripled during the past 30 years. Getting the disease under control is paramount to survival. In a study of dogs treated with Vetsulin, investigators reported adequate glycemic control was achieved an average of 81 per cent of the time during the study period, and in a pivotal US study of diabetic cats, Vetsulin reduced all major diabetes indicators to within normal range by day 60 of treatment.

Today, dogs receiving the proper treatment have the same expected lifespan as a non-diabetic dog of the same age and gender, while only 50 per cent of dogs used to survive the first 60 days following a diagnosis of diabetes. With effective treatment, lifestyle changes and monitoring, a diabetic cat also can have the same expected life span as a non-diabetic cat of the same age.

Merck Animal Health is committed to supporting veterinarians in the ongoing treatment of their patients, including making diabetes professionals available to answer questions.

Vetsulin should not be used in dogs or cats known to have a systemic allergy to pork or pork products. Vetsulin is contraindicated during periods of hypoglycemia. Keep out of reach of children. As with all insulin products, careful patient monitoring for hypoglycemia and hyperglycemia is essential to attain and maintain adequate glycemic control and prevent associated complications. Overdosage can result in profound hypoglycemia and death. The safety and effectiveness of Vetsulin in puppies and kittens, breeding, pregnant, and lactating dogs and cats has not been evaluated. See package insert for full information regarding contraindications, warnings, and precautions.

Source: PharmaBiz

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