FDA Approves Bristol Myers MS Drug, But Pandemic Will Delay Launch

Xconomy New York — 

A multiple sclerosis drug that came to Bristol Myers Squibb via its acquisition of Celgene last year was approved Thursday but don’t expect it to reach patients any time soon. The company says the drug’s launch will be delayed due to the coronavirus pandemic.

The Bristol (NYSE: BMY) drug, ozanimod (Zeposia), is one of the medicines approaching commercialization that the pharmaceutical giant touted as justification for its $74 billion buyout of Celgene. Some analysts have projected that the drug could become a blockbuster seller. But when ozanimod does reach the market, it will compete against other MS medicines in the same drug class. Bristol has not yet disclosed the price for its new once-daily MS pill.

In MS, the immune system attacks myelin, the protective sheath that covers the nerves. The damage makes it more difficult for signals to travel between nerve cells. Ozanimod is a type of autoimmune drug called a spingosine 1-phosphate (S1P) receptor modulator. It’s designed to bind to two S1P receptors, blocking immune cells called lymphocytes from leaving the lymph nodes.

Bristol says the exact way that ozanimod produces its therapeutic effect in MS is not known, but it may involve the reduction of the movement of lymphocytes into the central nervous system. The drug is also in testing as a potential treatment for other autoimmune disorders, including ulcerative colitis and Crohn’s disease.

Regulatory approval for ozanimod covers adults who have relapsing forms of multiple sclerosis, which is characterized by flareups of the neurological symptoms of the disease followed by periods of partial recovery. The FDA based its decision on two Phase 3 tests enrolling more than 2,600 patients that evaluated the drug against interferon beta 1a (Avonex), a commonly prescribed injectable Biogen (NASDAQ: BIIB) treatment for the relapsing form of MS.

Results from the studies showed a 48 percent reduction in the annualized relapse rate in patients treated with the Bristol drug after one year compared to the group given interferon beta 1a. That reduction was 38 percent at the two-year mark. The data also showed that ozanimod-treated patients had a greater reduction in the number and size of brain lesions. The most common adverse reactions to the treatment were upper respiratory infections, higher levels of liver enzymes, urinary tract infection, back pain, and blood pressure changes.

When ozanimod reaches the market, it will compete against two S1P receptor modulators from Novartis (NYSE: NVS). Fingolimod (Gilenya), which accounted for $3.2 billion in 2019 sales, has lost its patent protection. Another Novartis S1P receptor modulator, siponimod (Mayzent), was approved by the FDA a year ago.

FDA approval of ozanimod marks the latest step in a long, twisting path. The drug was initially developed by Receptos, a San Diego biotech that was acquired by Celgene in 2015 for $7.2 billion. Celgene continued development of the drug, which produced positive data in late-stage studies. But in 2018, the FDA refused to review the company’s submission for ozanimod, saying that the paperwork was lacking information. That application was resubmitted to the FDA a year ago.

In its announcement of ozanimod’s approval, Bristol says that the COVID-19 pandemic led it to delay commercialization of the drug. The company added that the decision was based on “what’s in the best health interest of our patients, customers and employees.” An application for approval has been filed in the European Union. A regulatory decision there is expected in the first half of this year.

Image: iStock/Christoph Burgstedt