Pharmacologists at 150 ADR centres to work as experts to assist DCGI in drug approvals

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Faced with crunch of sufficient experienced pharmacologists in the new drug advisory committees (NDACs), the Drug Controller General of India will tap the strong pool of senior pharmacologists available with Adverse Drug Reaction (ADR) centres in the country.

This was decided after it was found that many NDACs could not deliberate and take a decision on approval of clinical trials and drug approvals properly due to the absence of pharmacologists during the meetings.

The decision is to make use of the pharmacologists available at the 150 ADR monitoring centres under the Pharmacovigilance Programme of India (PvPI), as they happen to be senior pharmacologists of the medical colleges. They will be treated as a panel of experts and the DCGI would call them for the meetings as per the need of the proposal. This will make sure that one or more pharmacologist would be present in every meeting.

It has been pointed out that several applications for drugs and trials were being held up as pharmacologists, who are part of the NDACs, were not present during deliberations. The Apex Committee on clinical trials headed by the health secretary has also reportedly taken note of the situation. The Technical Committee has found that some NDACs even made recommendations even without proper representation of specialists including pharmacologists in several cases in the past.

The functioning of the NDACs has been hit after some members retired and  some of the members are no more associated with the organisation and some had refused to attend the meetings, citing busy schedules and engagements. Te practice is that the pharmacologist specified for particular NDACs are only called to offer expert opinion, not full-time attendance at the meetings.

The apex committee has already directed that whenever a pharmacologist in the panel is absent, the minutes of the NDACs along with the presentation of the firms and supporting literature should be referred to the pharmacologist approved in the panel of NDAC for his opinion.

Source: PharmaBiz

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GSK’s once-weekly diabetes treatment, Eperzan receives European marketing authorisation

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The European Commission has granted marketing authorisation for GlaxoSmithKline’s once-weekly diabetes treatment, Eperzan (albiglutide).
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as: Monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance; Add-on combination therapy, in combination with other glucose-lowering medicinal products, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Vlad Hogenhuis, senior vice-president and head, GSK Global Cardiovascular, Metabolic and Neurosciences (CVM&NS) Franchise, said, “Diabetes treatment can be challenging for healthcare professionals and patients, often involving complex daily regimens, with almost 50 per cent of patients failing to meet their blood glucose targets. The authorisation of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well tolerated.”

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen and supplied with a short (5mm) thin-wall needle.  GLP-1 is an important incretin hormone that helps normalise blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent. The EMA authorisation of albiglutide is based on the results of the comprehensive Harmony programme, comprising eight phase III studies.

The Harmony programme involved over 5,000 patients and evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment.   While many diabetes registration trials are just six months in duration, five of the Harmony trials included patient follow-up for up to three years.

GSK expects to launch albiglutide in several countries in Europe in Q3-4 2014 with additional launches to follow thereafter.

Albiglutide is currently undergoing review by other authorities, including the US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014.

Eperzan is a trademark of the GlaxoSmithKline group of companies.

Source: PharmaBiz

Otsuka Pharma’s ADPKD drug, Samsca receives Japanese approval

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Otsuka Pharmaceutical’s Samsca (tolvaptan) has been approved in Japan in 7.5-mg and 15-mg tablet forms for extended use for the additional indication of autosomal dominant polycystic kidney disease (ADPKD). Also, the new dosage form of 30-mg Samsca tablets has received approval for the indication of ADPKD.

Otsuka has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease, a company press release said.

Samsca was developed over the past 26 years by the efforts of many researchers in Otsuka’s Tokushima, Japan research facility. It is currently used in 14 countries and territories around the world as an aquaretic drug, which facilitates excretion of only free water without electrolyte loss due to its antagonist action on vasopressin V2 receptors. Upon a discovery that proliferation and enlargement of renal cysts are hindered by suppression of cAMP formation at vasopressin V2 receptors, Otsuka launched a new effort from 2004 to develop a drug for the rare disease ADPKD, in conjunction with world specialists including Dr. Vicente E. Torres of the Mayo Clinic in the US.  In global clinical trials (the TEMPO 3:4 trial) conducted in 15 countries on more than 1,400 patients with ADPKD, Samsca was shown to significantly suppress the rate of increase in total kidney volume by approximately 50 per cent more than a placebo. The results of these trials were published in November, 2012 in the New England Journal of Medicine.

Taro Iwamoto, CEO of Otsuka Pharmaceutical Co., Ltd., stated, “Development of a pharmacotherapy for ADPKD, a rare disease leading to end stage renal failure, has been difficult. Lack of a fundamental therapy for this disease has over many years been a great difficulty for people with ADPKD. We are very pleased that, through this approval, we may be able to contribute something to these patients and their families. Through Samsca’s completely new mode of action, development of a new category of indications was possible. While rigorously pursuing safety and effectiveness, in the future we look forward to having something to present to patients who suffer from this disease, not only in Japan but all over the world.”

Eiji Higashihara, professor of nephrology at Kyorin University School of Medicine, noted, “Since there has been no drug treatment for ADPKD up to now, this recent approval is great news for these patients and their families, and also for those of us who treat them. On the other hand, physicians and other health care workers need to thoroughly know the indications of Samsca for treatment of ADPKD. We further need to keep in close touch with the patients and their families in paying attention to safe use of Samsca. It is important that, through teamwork, we carefully nurture this medicine that has been developed here in Japan.”

In Europe, as of December, 2013, an application for regulatory approval of tolvaptan in ADPKD had been received and is under review. In the United States, based on a review issued by the FDA, we have continued discussions with them regarding supplementary data and the path forward for resubmission.

ADPKD is a disease arising from one of two possible genetic mutations in which innumerable cysts (sacs in which fluid accumulates) form on both kidneys to such a degree that the kidneys become multiple times larger than normal, leading to gradual diminution of renal function. If either parent has ADPKD, a child has a one-in-two probability of inheriting the disease. In most cases symptoms begin to show up in the third or fourth decade of life in the form of complaints such as blood in the urine, abdominal or low back pain, and abdominal distention. Before the kidneys start to malfunction hypertension often occurs, with complications like cerebral aneurysms and hepatic cysts occurring more frequently than usual. By age 70, close to half of ADPKD patients are estimated to have end-stage renal failure, necessitating dialysis or renal transplantation. ADPKD is the fourth-leading cause of end-stage renal failure.viii The disease occurs relatively frequently among genetic disorders, with approximately 30,000 people diagnosed in Japan, 200,000 in Europe and 120,000 in the US.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

Source: PharmaBiz

Action plan to save crisis hit Ayurveda units in Kerala

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In order to save the struggling Ayurveda drug manufacturing units in Kerala owing to shortage of raw materials, a drug inspector in Thiruvananthapuram district has chalked out a comprehensive action plan to be submitted to the state government. The report was prepared on the pressure of manufactures and traders of the traditional medicine sector.

Due to non-availability of essential  raw drugs, many companies have stopped or cut the production of several traditional drugs in their plants. Prices of those medicines of the units are steadily going up in the state.

The drug inspector, after a long period of research and study, drafted the action plan on the pressure and support of leading manufacturers in Kerala and from Coimbatore. He will submit the report which is expected to bring revolutionary changes in the drug manufacturing side of Ayurveda and save many a suffering units in the state provided it is implemented in its true spirit. Before preparing the plan report, the drug inspector, Dr P Y John, had convened two meetings of manufacturers at Thrissur and at Ernakulam, the central zone of Ayurveda department where he was working as the DI.

His plan report mainly envisages a consortium of five departments, each one of them can contribute its services to the development of the traditional industry. Dr John says if support from government agencies is given to the industry, it will grow like anything, for which government should come forward with some projects. According to him five departments such as Ayurveda, drug control department, biotechnology, agriculture and forest should join together and form a consortium under a project officer. To materialise this action plan, a serious approach from the government is required. He submit the report to the government after the Lok Sabha election.

In the meetings he convened in the central zone, the manufacturers have elaborated their problems arising due to shortage of raw materials. They said they are unable to produce all the drugs now, and those produced are also not in the required quantity. The only solution to this crisis is to grow medicinal plants for future use and import the materials for the needs of the companies at present. This will be possible only with the intervention of the government which should initiate projects for cultivation of raw materials as per the requirements.

To a question Dr John said, the state medicinal plant board, though it is supposed to take care of this issue, is doing nothing towards solving the raw material crisis. He said first of all, the board should be strengthened and it should study the needs of the manufacturing industry. He further said the Oushadha Keralam show conducted in Thrissur in December last year did not fetch any desired result.

His other suggestion for upbringing the Ayurveda sector is establishment of a health services institute like the one operating for allopathy system in the state capital. Ayurveda also needs such an institute to train the doctors, academicians, students, researchers and industry people.  The institute can provide training and refresher courses to the Ayush doctors.

“The north Indian ‘Kiriyath’ (Andrographis paniculata ) is therapeutically very active, but the product available in Kerala is inferior in quality. It is used for various drugs. Likewise,  ‘Maramanjal’ (Cosenium fenestrum )  available in north India is found more active, but those found in Kerala is less in quality .  These differences have to be studied and analysed by researchers and found out which variety is more active. Then we can identify such herbs and cultivate it. So, the government should conduct a comprehensive study on the part of the availability of raw materials and undertake projects for scientific cultivation of medicinal plants and other raw drugs”, he said.

Dr John added that the government should take steps to form the Ayush department. The cluster in Thrissur can be converted into a research institute for the sake of the industry.

Source: PharmaBiz

Maximum number of trials by one investigator may be limited to 3 at a time

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The Health Ministry, as part of further streamlining the clinical sector, may put restrictions on the number of trials that one investigator can take up. However, the authorities would further consult the stakeholders before taking a final decision.

The proposal is being made as the follow-up to the recommendations by the Prof Ranjit Roy Chauhury Expert Committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. The government had already directed that the number of trials an investigator can undertake should be commensurate with the nature of the trial and facility available with the investigator.

The ministry is planning to put the maximum number as three for an investigator to undertake the trials at the same time. Apart from the investigators at the established research organisations which participate at multiple trials, it is alleged that some doctors in hospitals do not mind being involved in any number of trials, thus affecting the very quality of the trials.

Sources said the industry has already opposed the plan and made several representations against the proposal. They have asked the ministry to reconsider the decision to limit the number of trials supervised by an investigator.

According to the industry, the time required to spend on a clinical trial vary from study to study and from stage to stage in a given study. For example, OPD-based study required less time when compared to in-patients studies or study in critically ill patients.  The involvement of an investigator is minimal as per the nature of the study. Putting a number cap abruptly would result in de-growth of current good sites and investigators, as well developed research establishments which cannot participate in multiple studies, even though they have capabilities, staff and infrastructure.

In view of the representations, the ministry has decided to hold more deliberations involving the stakeholders and take an action accordingly. The matter has been discussed already by the technical committee set up by the government. Sources said the apex committee headed by the Health Secretary also went through the proposal, but did not take a final decision.

Source: PharmaBiz