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New MS treatment shows promise, awaits FDA approval

St. Vincent Healthcare's Dr. Kris French

A promising new MS treatment has doctors and patients alike cautiously hopeful that it can help people with a previously untreatable form of the disease.

But before that can happen, it needs approval by the U.S. Food and Drug Administration (FDA), a process that started earlier this year when the federal agency granted the drug an important priority review status and could see an approval decision handed down before the end of 2016.

There's excitement and hope, but we're guarded because of how things go with medication approvals," said Dr. Kris French, a neurologist and medical director of St. Vincent Healthcare's Multiple Sclerosis Center. "I think with every success we see,  10 failures."

The treatment is called Ocrevus — its generic name is ocrelizumab — and, if approved, would be the first treatment available to people with primary progressive MS.

MS is a central nervous system disease that causes communication problems between the brain and the rest of the body. It can eventually cause nerve deterioration or permanent damage.

There's no cure for the disease so far, but there are multiple treatments for its most common form, called relapsing-remitting MS, characterized by occasional flare-ups of new or worsening symptoms followed by remission in which the symptoms partially or completely disappear.

But for primary progressive MS (PPMS), which sees continually worsening symptoms with no remission and affects 10 to 15 percent of people diagnosed with MS, there are no effective treatments currently.

That could change, though, if the FDA finds Ocrevus acceptable and grants it approval. It could also be used to treat relapsing-remitting MS.

"It's the first that could be used to treat primary progressive MS," French said. "It's a  form and right now, it's a bad diagnosis. Every medication that is currently available for MS treats relapsing."

While it's difficult to pinpoint exact numbers, French said that in the Billings area, around 1,000 people are living with MS, meaning that there are about 150 people with PPMS. If it gains FDA approval before the end of the year, he expects Ocrevus to be available in Billings by the spring of 2017.

Part of the difficulty in treating PPMS is that there are still a lot of unknowns about the disease.

"We just don't know that much about how it works," French said.

The treatment, made by Swiss biotech company Roche, is designed to target  immune cells to slow the disease's progression while still allowing the body's immune system to fight off infections, a problem other treatments and drugs haven't been able to solve for PPMS.

Clinical trials by Roche ended with encouraging results. A September investor update from the company indicated that a "47 percent higher proportion" of PPMS patients using Ocrevus showed no progression compared to those taking a placebo.

"These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS," said Gavin Giovannoni, a member  the the scientific steering committee for two of the trials and neurology chair at Barts and the London School of Medicine and Dentistry, in the investor update.

In addition, patients in its trials who received the treatment via two intravenous transfusions given two weeks apart every six months showed a 24 percent reduction in progression risk.

While the results of the clinical trials are exciting, French also cautioned that it's important to wait for the FDA's findings and recommendation, since he's seen many drugs that showed promise end up without approval for numerous reasons.

But if it does work as advertised, it could be an important resource for treating both forms of MS.

"If somebody was just diagnosed, that's huge," French said. "But for somebody who's already had it for a long time, maybe they notice parts of it getting worse each year. This could slow down that progression, too. There's nothing else currently available for them."

The FDA's granting of Priority Review Designation means the agency views it as potentially providing improvements to the effectiveness or safety of treatment compared to current standards and that it will expedite its review process.

In addition, it granted the treatment Breakthrough Therapy Designation based on the clinical trials. That designation means the FDA views it as a treatment that treats a serious or  disease or condition and which shows that it could have  improvement on existing therapies.

"While the reported effects for ocrelizumab on progression are modest, the data clearly indicate that this treatment has potential benefit and is not only a source of hope, but also an important milestone that will further inform development for effect treatments for everyone with progressive forms of MS," said Alan Thompson, chairman of the International Progressive MS Alliance Scientific Steering Committee, in a public statement on the drug's priority review status.

The alliance said that it expects an FDA decision by Dec. 28.

French said that if it gains federal approval, Ocrevus could be available in Billings a few months into 2017, after the FDA sets and implements monitoring requirements and physicians and other medical personnel are trained on its use.

He said that people dealing with any form of MS still must continue doing all of the other lifestyle things they do to manage their disease — a proper diet, getting exercise, stopping or avoiding smoking, managing other co-morbidities and other things that can have an impact on the immune system — and that, hopefully, Ocrevus can help them in the future.

Story Source: The above story is based on materials provided by BILLINGSGAZETTE
Note: Materials may be edited for content and length

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