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
Researchers Identify Role of ApoE4 Gene as Possible Drug Target in Alzheimer’s Disease

September 21, 2017 - A team of neurology researchers at Washington University School of Medicine in St. Louis have found that in the presence of the ApoE4 protein, another protein known as tau forms tangles in the brain which contributes to neuronal damage characteristic of Alzheimer’s disease.

Featured In: Life Science News


New Guidelines Address CAR-T Immunotherapy Toxicities to Prevent Patient Deaths

September 20, 2017 - Clinicians at The University of Texas MD Anderson Cancer Center have published new guidelines in the journal, Nature Reviews Clinical Oncology, which could help in the management of these toxicities.

Featured In: Biotech News, Drug Safety News


Microneedle Skin Patch Could Treat Common Metabolic Disorders

September 19, 2017 - Researchers at Columbia University Medical Center (CUMC) and the University of North Carolina have developed a microneedle skin patch impregnated with a drug capable of converting white fat into calorie-burning brown fat.

Featured In: Medical Device News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub

REGISTER FOR THESE WEBINARS

Development and Manufacture of Highly Potent API Drug Products Throughout the Clinical Phases


Innovation through Integration – Providing Next Generation Biomedical Devices and Interconnects


Clinical Payments Case Studies: Improving Efficiency, Cash Management, and Compliance


Why Phase 3 Trials Fail: Oncology Case Studies and Lessons Learned


Copyright © 2016-2017 Honeycomb Worldwide Inc.