FDA Breakthrough status for Astellas/Affinivax pneumonia candidate

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older.

ASP3772 is under development by US biotech Affinivax and Japan’s Astellas Pharma (TYO: 4503, which acquired worldwide licensing rights to the product in February 2017 based on an upfront payment of $10 million.

The FDA decision is informed by the results of the Phase II data. The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. Designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.