BmS multiple sclerosis drug ozanimod has broken through the European market after it was approved in the United States.

BMS has announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review of the recommendation to approve Zeposia (ozanimod) for the treatment of recurrent remission-type multiple sclerosis (RRMS) adult patients.
just a few days ago (March 25 local time), Zeposia was officially approved by the U.S. FDA for the treatment of recurrent multiple sclerosis (RMS) in adults, including clinical isolation syndrome, recurrent remission multiple sclerosis, and active progressive multiple sclerosis.
this time to be positively recommended by CHMP, it looks like Zeposia is also on track to make a breakthrough in the European market.
CHMP's positive recommendation on Zeposia will be submitted to the European Commission (EC) for a final review, which will make a final regulatory decision within 2 months.
CHMP recommendations and FDA approvals are based on the largest scale, head-to-head critical Phase III clinical trials sunBEAM and RADIANCE Part B research data ever conducted in MS patients.
the two studies involved more than 2,600 patients in 150 regions in more than 20 countries, with the main clinical endpoint being annual recurrence rate (ARR).
data show that, for 12 months of treatment compared to Avonex, Zeposia reduced ARR by 48% (ARR: 0.18 vs 0.35); in addition to
, Zeposia also reduces the number and size of brain damage lesions.
Zeposia is an oral selective pyridine alcohol 1-phosphate (S1P) receptor regulator that selectively binds to S1P subtypes 1 (S1P1) and 5 (S1P5) with high affinity.
originally developed by Receptos and later acquired by New Base, the drug's approval is the first FDA-approved new drug application since BMS completed its acquisition of new base.
Zeposia's active recommendation in Europe, it is also expected to expand BMS's franchise in the field of immunology.
MS is a protective myelin disease in which the immune system attacks the nerves.
myelin damage can disrupt communication between the brain and the rest of the body.
eventually, the nerves themselves may deteriorate, a process that is currently irreversible.
MS affects about 2.5 million people worldwide and about 700,000 people in Europe.
, three S1P receptor regulators have been approved for sale worldwide, with the exception of Zeposia, both of which come from Novartis: Fingolimod, Gilenya, a generation of S1P receptor regulators, and S1PR1/S1PR5 regulator Sipimomod, Mayzent.
and Zeposia is currently the only option available for start-up RMS adult patients, the drug does not require genetic testing, no first dose test, and the drug is very convenient, only once a day oral. Samit Hirawat, Chief Medical Officer of
BMS, said: "ChMP's positive comments further demonstrate that Zeposia has the potential to be an important treatment option for patients with recurrent multiple sclerosis.
clinically still need effective and safe drugs to treat the recurrence of the disease and brain lesions, and expect further decisions from the European Commission.
" Source: 1.Bristol Myers Squibb Receives Positive CHMP Opinion Ing-of-ZEPOSIA Ozanimod for The Treatment of Adult Patients with Relapsing Rgos - Multiple Sclero 2.FDA s BMS' Zeposia for MultipleS 3. Relapsing R Multiplemores with Active Disease.