FDA Approves First Drug To Treat Primary Progressive MS | Care2 … – Care2.com

The U.S. Food and Drug Administration has approveda first-of-its-kind treatment that can halt the progress of aggressive MS symptoms. Heres what you need to know about this important drug therapy.

While various MS treatments already exist on the market, options for those with primary progressive MS, have been incredibly limited.

Primary progressive MS differs from the relapsing and remitting variety in that symptoms like muscle weakness and loss of motor function gradually worsen, rather than emergingas sudden attacks.

Available treatments canhelp manage specific symptoms of the disease, but none on the market have been able to target the progressive debilitation caused by this variety of MS until now.

A newly approved drug, known asOcrevus, is given through an intravenous infusion by a health care professional every six months. In trials the drug showed a significant ability to interrupt the cycle of relapses for those with the more commonly understood relapsing and remitting MS.

In addition, Ocrevus displayedwhat has been described as a modest ability to slow deterioration inpatients with primary progressive MS. While that might not sound particularlyencouraging, health experts claimthat it is a significant step forward.

Multiple sclerosis can have a profound impact on a persons life, Dr. Billy Dunn, director of the Division of Neurology Products in the FDAs Center for Drug Evaluation and Research, stated. 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.

And this isnt just encouraging newsfor primary progressive MS. The current raft of treatments for all types of MS comes with significant side effects, Many physicians are reluctant to prescribe them until symptoms makethe trade-offworthwhile.

The FDA found Ocrevus to berelatively safe and come withmore manageable side effects than many other treatments. Among the potential side effects, the FDA identifieda likelihood of reactions at the injection site. Other complications included a greater risk of upper and lower respiratory infections and an increased likelihood of cold sore breakouts, as well as symptomslike fatigue, headaches and skin issues.

As general side effects go, these are considered to be manageable for most patients. However, researchers identified one major drawback: there appears to be a slightly higher risk of tumors in MS patients taking Ocrevus specifically breast cancer.

This apparent side effect may prove to be far more remote when the drug goes on the market, but until then,physicians are keen to monitor patients carefully to ensure that the risk is minimal.

That said, its worth putting this risk in perspective: Many MS patients may consider a slightly increased risk of tumors an acceptable trade-off for a higher quality of life whentheir MS symptoms are controlled or halted. The risk can also be managed withincreased cancer screenings for at-riskpatients.

Besides effectiveness, the key question surroundingany new drug is, of course, price. And surprisingly, there is some good news on that front.

Ocrevus manufacturers buck the trend, pricing their drug significantly lower than its competitor.

In a bold move, the Swiss-owned company Genetech has announced that it will charge $65,000 per year as the list price for this drug. While Ocrevusremainsundeniably expensive, the costis 25 percent less than the current market leader for MS treatment, known as Rebif.

The New York Timesreports that this was a deliberate move by Genetech:

Rebif, sold in the United States by the German company EMD Serono, carries a list price of about $86,000. In a statement, Genentech noted that the price of drugs to treat multiple sclerosis had risen sharply in recent years.

We feel that the industry needs to start to reverse this trend, and believe that pricing Ocrevus 25 percent less than the comparator in our trials is an important first step, the company said.

And in the trials that have underpinned the drugsmarket approval, Ocrevus appeared to outperform Rebif.

The real test, however, will beto see if the company can resist the market trend of increasingdrug prices once they have locked in a consumer base. But the very fact that they have made a visible stance against a problem that has drawn widespread condemnation in the U.S. even prompting a series ofCongressional reviewsis marked.

Clearly,Ocrevus is not a magic cure for primary progressive MS. Even so, patients involved in the trial say that where they once envisioned onlyfive to ten years before their symptoms left them bedridden, they couldnow potentially have a few decades ofindependence and that value cannot be underestimated.

Of course, we cant get ahead of ourselves. Many drugs have performed well in initialtests, only to fail to live up to their promise later. That said, it is undeniable that this MS drug is reinvigorating an area of treatmentthat had been stagnant for many years.Drug research efforts remain crucial in building better treatments for patients and,ultimately, in discovering a potential cure for MS.

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