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New Drug treatment meant for Multiple Sclerosis Approved by the FDA

Apr 11, 2017

New Drug treatment meant for Multiple Sclerosis Approved by the FDA

On March 28, the United States Food and Drug Administration sanctioned approval to Ocrevus (ocrelizumab) for treating patients suffering from a rare relapsing form of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This the first ever drug for PPMS that has received an approval from the FDA. It offers hope to patients who earlier had no alternate options to fight a persistent disease which results to cognitive decline and paralysis.

Ocrevus is a drug that is infused intravenously by a medical care professional. Dr. Jerry Wolinsky, professor emeritus at the University of Texas in Houston said: "We've been banging on a wall with a bunch of drugs, and we finally put a big crack in the wall." He was the leading author on the January study which showcased that ocrelizumab drug positively slowed the deterioration in patients suffering from primary progressive multiple sclerosis.

Multiple Sclerosis is a neurological disease affecting hundreds of thousands of people, especially women, in the United States. It is an inflammatory, chronic, autoimmune disease of the central nervous system, which interrupts the communication amidst the brain and the other parts of the body. It has been termed as the most common type of neurological disability especially in young adults. The disease cicatrices nerve tissues and leads to varied symptoms, right from vision problems to paralysis.

The researchers say that the drug is much effective than at shutting down inflammation. Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said, “Multiple sclerosis can have a profound impact on a person’s life. This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

For most of the MS patients, sequences of degenerated functions are primarily followed by recovery periods. In due course of time, recovery might be incomplete, resulting in progressive decline in function and escalated disability. Between the ages of 20 and 40, most of the people experience their initial symptoms.

A multiple sclerosis researcher and the chair of neurology at Yale School of Medicine, Dr. David Hafler, has thoroughly researched the drug, however did not take part in the trials resulting to the FDA approval. Even though he does not get any consulting fees from Genentech, the drug’s maker, his lab received limited funding from the company to study whether how the drug works.

Ocrevus is and infusion drug which has to be given every six months. It functions by eliminating a class of immune cell, called B cells which have a key role in the disease. Also, this latest development changes the spotlight from other  therapeutics present in the market that has solely targeted T cells and ultimately has been hugely ineffective in the treatment of primary progressive multiple sclerosis.

Genentech says that Ocrevus will be available in the market within two weeks at a list price of $65,000 each year. A study done in 2015 portrayed that the first gen drugs which once cost $8,000 to $11,000 per year, increase nearly to $60,000 per year.

Dr Hafler estimates that the insurers will be satisfied with the quoted price and make Ocrevus easily available to all the MS patients than had the cost been dearer. Moreover, the $65,000 price tag, was acclaimed by The National Multiple Sclerosis Society.

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