Celgene submits apremilast NDA, reports earns

Celgene Corp. (NASDAQ:CELG) disclosed in its 1Q13 earnings that it submitted an NDA to FDA in March for apremilast to treat active psoriatic arthritis. Next half, the biotech plans to submit an sNDA to FDA for the oral phosphodiesterase-4 (PDE-4) inhibitor for moderate-to-severe plaque psoriasis, and a combined MAA to EMA for both indications.

Celgene also reported that once-daily oral pomalidomide missed the primary endpoint vs. placebo in the Phase III RESUME (MF-002) trial to treat myeloproliferative-neoplasm-associated myelofibrosis. The endpoint was the proportion of subjects achieving red blood cell (RBC)-transfusion-independence. Celgene declined to disclose details, including next steps for the indication. In February, FDA approved the thalidomide analog as Pomalyst to treat multiple myeloma (MM) (see BioCentury Extra, Feb. 8). ...