Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Grants Priority Review To Roche’s Multiple Sclerosis Drug

XTALKS VITALS NEWS

Roche

The Swiss drugmaker is looking to include both relapsing multiple sclerosis and primary progressive multiple sclerosis on the drug’s list of indications.

Share this!

Tweet: Roche’s Ocrevus for #multiplesclerosis has been granted #FDA priority review status http://ctt.ec/azpej+Roche’s Ocrevus for multiple sclerosis has been granted FDA priority review status.

Tweet: Sales of Roche’s Ocrevus are expected to reach between $3 billion and $7 billion http://ctt.ec/yK88B+Sales of Roche’s Ocrevus are expected to reach between $3 billion and $7 billion.

June 29, 2016 | by Sarah Massey, M.Sc.

Roche’s Ocrevus (ocrelizumab), a new drug designed to treat a form of multiple sclerosis for which no treatments are available, has been granted priority review status by the US Food and Drug Administration (FDA). The decision could lead to accelerated approval of the drug, which means the biologic could hit the market by the end of 2016.

The Swiss drugmaker is looking to include both relapsing multiple sclerosis and primary progressive multiple sclerosis on the drug’s list of indications. While there are multiple treatments on the market for relapsing multiple sclerosis – including those from Novartis, Merck, Biogen, Sanofi and Teva – there are no approved treatments for the progressive form of the disease.

It’s estimated that 10 to 15 percent of all patients with multiple sclerosis suffer from the progressive subtype. In clinical trials, Roche’s Ocrevus was a more effective treatment for relapsing multiple sclerosis compared to Merck’s injectable, Rebif. What’s more, the biologic reduced the risk of disability progression in patients with primary progressive multiple sclerosis by 24 percent, over the placebo.

“Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS,” said Dr. Sandra Horning, chief medical officer and head of Global Product Development. “We are pleased by the FDA’s decision to classify their review of the biologics license application as priority because we believe Ocrevus has the potential to help people living with either of these two forms of MS. We will continue to work closely with the FDA and European Medicines Agency (EMA) to bring this investigational medicine to people with MS as quickly as possible.”



Roche also expects the drug to win EMA approval by mid-2017. If approved, the drug would be the first to provide a treatment option for 95 percent of all multiple sclerosis patients.

Due to its blockbuster potential, sales of the biologic are expected to reach between $3 billion and $7 billion at its peak. The revenue could prove essential for Roche as many of its cancer drugs may soon face biosimilar competition.

A small French biotech company, MedDay, is currently also developing a biologic for primary progressive multiple sclerosis. Their drug candidate, MD1003, is being tested in a Phase III clinical trial. The company hopes to win European approval for the drug in 2017, with plans to file an FDA application later on.


Keywords: Multiple Sclerosis, FDA, Priority Review


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis

March 22, 2017 - According to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder.

Featured In: Drug Safety News


PTC to Acquire Marathon’s Recently Approved Duchenne Muscular Dystrophy Drug

March 17, 2017 - Amid a drug pricing controversy, PTC Therapeutics has agreed to buy Marathon Pharmaceuticals’ Duchenne muscular dystrophy (DMD) drug, Emflaza.

Featured In: Pharmaceutical News


Memphis Meats Produces World’s First Poultry from Animal Cells

March 17, 2017 - Silicon Valley-based food manufacturing company, Memphis Meats, has produced the world’s first “clean poultry” by growing chicken and duck cells outside the animals.

Featured In: Food News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

How to Improve the Speed and Efficiency of Your Clinical Trials


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.