CHMP

Vumerity Recommended for EU Approval as RRMS Treatment

A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…

Ponvory Recommended for Approval in EU for Relapsing Forms of MS

A branch of the European Medicines Agency has recommended that PonvoryĀ (ponesimod) be approved to treat relapsing forms of multiple sclerosisĀ (MS) in adults with active disease. This positive opinion from agency’s Committee for Medicinal Products for Human Use (CHMP) covers clinically isolated syndrome,Ā relapsing-remitting MSĀ (RRMS), andĀ active secondary…

CHMP Favors Kesimpta for Adults With Relapsing MS in Europe

A branch of the European Medicines Agency (EMA) has recommended thatĀ Kesimpta (ofatumumab) be approved and made available to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. A final decision from the European Commission (EC) is expected in about two months. Typically, the EC follows…

Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS

Europeans with relapsing multiple sclerosis (MS) andĀ earlyĀ primary progressive MS are one step closer to accessingĀ Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion ā€” announced inĀ a press release issued Nov. 10 by the EMAā€™s Committee for Medicinal Products for Human UseĀ ā€” is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whetherĀ OcrevusĀ should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens,Ā any decisions on price or insurance reimbursements will be the responsibility of each member state. OcrevusĀ wonĀ U.S. approval earlier this year. It was alsoĀ recentlyĀ approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division ofĀ Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Seronoā€™s approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.

Cladribine Tablets Are Only a Step Away from European Union Approval for Relapsing Multiple Sclerosis

Merckā€™sĀ cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human UseĀ has recommended that the European Commission approve theĀ tablets. ā€œThe positive opinion from the CHMPĀ [the committee] is an extraordinary…