Clinical Overview of Innovative New Drug Approvals in 2017

Abstract

The FDA has approved 46 new drugs in 2017, another record approval in two decades on a similar pace to the gangbuster year of 2015. Many of these new medicines address significant and meaningful needs, or offer additional therapeutic choices for patients worldwide. These new drugs also cover a broad range of indications including immuno-oncology (Imfinzi and Bavencio), Parkinson’s disease (Xadago), eczema (Dupixent), psoriasis (Siliq and Tremfya), multiple sclerosis (Ocrevus), and different types of cancer (Idhifa, Aliqopa, Calquence, and Besponsa).  A few important orphan drugs were approved, including in mucopoly-saccharidosis type VII (Mepsevil) and Batten’s Disease (Brineuria). Many of these new drugs are for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Yet the pharma companies saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from biotech companies. Recently, the US has introduced the Right-to-Try Act, wherein patients can access experimental treatments if they are unable to participate in any clinical trial of new drugs and if they have no other options. Such policies are expected to increase the database for new experimental drugs and help accelerate drug approvals.