The Food and Drug Administration is poised to begin filling as many as 10,000 request form-actions for Pfizer’s arthritis drug Zegerid for adults before its original policy deadline, according to two people familiar with the situation.
The decision was largely due to the drugmaker’s urging that a more timely review is required for Zegerid because of its cardiovascular risk, according to one of the people. Zegerid’s effects on blood pressure and heart rates were such that the FDA has questioned the merits of approving the drug to go ahead without its most common class of medicines known as anti-platelet drugs, which were used to reduce the risk of blood clots, the person said.
Pfizer requested an additional 6 months from the FDA to allow some patients to complete an investigation. In a statement on Thursday, the New York-based company said the agency will decide later whether to formally grant it the request. It’s awaiting the results of patient and clinical trials, the statement said.
The FDA usually grants a six-month extension to companies that ask for data. FDA spokesman Michael Herndon declined to comment on the news or on whether Zegerid will be approved.
Zegerid, a drug that treats rheumatoid arthritis, treats up to 36% of patients who have no available treatment option to benefit from a standard, once-a-day pill, according to a Deutsche Bank (DB) model. It’s projected to generate sales of $2.2bn in 2025, from $367m in 2016, including royalties from Procter & Gamble Co.’s Gillette brand of razors and blades.
Zegerid is being closely watched for the effectiveness of its cardiovascular risk management strategy, which treats patients through a rotating schedule of repeat doses that prevent patients from dying of complications while Zegerid is under review.
The FDA is on course to move forward with the Zegerid approval, according to filings from Pfizer, which made the same request to the FDA last October.
In June, the FDA said that its Pharmacovigilance Advisory Committee would review all drugs that have a new indication for adults. If the committee recommends approval for the Pfizer medicine, the panel members will report back to the FDA on whether the study results are likely to affect the drug’s overall safety profile.
Zegerid is also under review by the European Medicines Agency and a pre-submission submission was filed with the FDA in November for another major market – Japan. The Japanese agency is to hold an advisory meeting on Zegerid’s application in November.