BMS Announces Positive CHMP Opinion for Zeposia (ozanimod) in RRMS Following U.S. FDA Approval
Bristol-Myers Squibb
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Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
Compiled by Fan Dongdong
Bristol-Myers Squibb (BMS) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Zeposia (ozanimod) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS).
Just a few days ago (on March 25, local time), Zeposia was officially approved by the U.S. FDA for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. With this positive recommendation from the CHMP, Zeposia appears poised to achieve a breakthrough in the European market as well. The CHMP’s positive opinion on Zeposia will be submitted to the European Commission (EC) for final review, and the EC will make its final regulatory decision within two months.
The CHMP’s recommendation and the FDA’s approval are both based on data from SUNBEAM and RADIANCE Part B, the largest head-to-head pivotal Phase III clinical trials conducted to date in patients with multiple sclerosis (MS). These two studies enrolled more than 2,600 patients across 150 sites in over 20 countries worldwide, with the annualized relapse rate (ARR) as the primary clinical endpoint. The data showed that, compared with Avonex, Zeposia reduced the ARR by 48% relatively after 12 months of treatment (ARR: 0.18 vs. 0.35) and by 38% relatively after 24 months of treatment (ARR: 0.17 vs. 0.28). Furthermore, Zeposia also reduced the number and volume of brain lesions.
Zeposia is an oral selective sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity and selectivity to S1P receptor subtypes 1 (S1P1) and 5 (S1P5). Originally developed by Receptos, it was later acquired by Celgene. The approval of this drug marks the first new drug application approved by the FDA since Bristol-Myers Squibb (BMS) completed its acquisition of Celgene. The recent positive recommendation for Zeposia in Europe is also expected to expand BMS’s franchise in the field of immunology.
Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath covering nerves. Damage to the myelin can disrupt communication between the brain and other parts of the body. Ultimately, the nerves themselves may deteriorate, a process that is currently irreversible. MS affects approximately 2.5 million people worldwide, including about 700,000 in Europe.
Currently, three S1P receptor modulators have been approved for marketing worldwide. In addition to Zeposia, the other two are both from Novartis: the first-generation S1P receptor modulator fingolimod (Gilenya) and the S1PR1/S1PR5 modulator siponimod (Mayzent). Zeposia is currently the only medication option available for adult patients with relapsing forms of multiple sclerosis (RMS) at the initial stage of treatment. This drug does not require genetic testing or first-dose monitoring, and it is very convenient to administer, requiring only once-daily oral dosing.
Samit Hirawat, Chief Medical Officer of Bristol-Myers Squibb, stated, “The CHMP’s positive opinion further demonstrates that Zeposia has the potential to become an important treatment option for patients with relapsing forms of multiple sclerosis. There remains a clinical need for effective and safe therapies to address relapses and brain lesions in this disease, and we look forward to the European Commission’s final decision.”
References:
1.Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval-of ZEPOSIA ozanimod for the Treatment of Adult Patients with Relapsing Remitting -Multiple Sclero
2.FDA approves BMS’ Zeposia for multiple sclerosis
3.Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of ZEPOSIA (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.