FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Baxalta Therapies Meet Primary Endpoints

Dec. 30, 2015

Baxalta and Momenta Pharmaceuticals had good news to report last week, with word that their proposed Humira biosimilar met the primary endpoint in a clinical study.

A total of 324 volunteers were enrolled in the study of the proposed Humira biosimilar, which showed bioequivalence in pharmacokinetics to the reference product.

Marketed by AbbVie, Humira is used to treat a number of conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.

The companies are planning to file for regulatory submission in 2017 and are targeting a 2018 launch date.

Separately, Baxalta’s Adynovate met its primary endpoint in a Phase 3 study with patients younger than 12. No patients developed inhibitory antibodies to Adynovate, which was approved last month in the U.S. to treat adolescent and adult hemophilia patients for on-demand treatment and control of bleeding, and prophylaxis to reduce the frequency of bleeding episodes.

Baxalta is planning to file for a pediatric indication in the U.S. early next year. In addition, it is eyeing a marketing authorization application for Europe. Adynovate currently is under review in Japan, Canada and Switzerland.