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FDA Finally Set To Approve Multiple Sclerosis Drug This March, Is There A Catch?

By Sai , Jan 29, 2017 08:23 PM EST
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Hope for Multiple Sclerosis patients has once again been revived after it was recently announced that the cure to overcome the illness is soon to be launched. Putting emphasis to those inflicted with progressive types of MS who have not found a drug that has the ability of working to reduce flares, improve symptoms, or slow disease progression. As of the press time, it was found that nearly 2.3 million people worldwide are living with the disease.

FDA On Approving Multiple Sclerosis Drug This March

According to reports revealed by Health Line, after series of delays, the Food and Drug Administration is finally set to approve a certain drug that is believed to have the ability in curing the disease late March this year. Officials from Roche Pharmaceuticals, the developer of the said cure has also claimed that for the first time ever, people with primary progressive MS (PPMS) may benefit from what they consider to be a medical breakthrough. During the large scale phase III trial, the drug named as Ocrevus has reportedly shown to significantly slow the progression of physical disability in people with PPMS. However, despite the success of these trials, the production of Ocrevus or also known as ocrelizumab has been delayed.

Why Has It Been Delayed?

Meanwhile, as per Multiple Sclerosis News Today, due to manufacturing issues, the long-awaited approval of FDA has been pushed to late March 2017. Additionally, Genentech, a member of the Roche Group, has explained that the U.S. Food and Drug Administration (FDA) has decided to extend the Prescription Drug User Fee Act (PDUFA) due to the submission of additional data by Genentech regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review. Furthermore, Genentech clarifies that the reason was actually contrary to the speculations that the reason was about the efficacy or safety of Ocrevus.

                

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