By Ray Tobey, Chief Medical Officer on Jan 10, 2018 9:00:00 AM
Even though 2016 was an unusually slow year for FDA drug approvals, in 2017 the number of new drugs sent to market more than doubled. Forty-six drugs, to be precise, passed FDA approval hitting a 21 year high.
Many of these new medicines address significant and meaningful needs, or offer additional therapeutic choices for patients and doctors alike. So why the increase? One contributing factor is that the FDA has taken advantage of policy changes to accelerate the drug approval process whereby the agencies breakthrough therapy designation has cut review times.
Also, with the increase of alternative funding models, young biotech companies are launching innovative new products at a much more aggressive pace then we’ve seen in previous years.
The new drugs cover a broad range of indications anywhere from neuro, autoimmunity, cancer, to rare diseases. For example, Xadago for Parkinson’s, Ocrevus for Multiple Sclerosis and Idhifa, Aliqopa, Calquence, and Besponsa, for different types of cancer and Mepsevil for mucopolysaccharidosis type VII and Brineuria for Batten’s Disease.
Importantly, the number of approved drugs does not include the cell and gene therapies from Novartis, Spark and Therapeutics and Gilead Sciences that were approved in 2017 since these are considered to be under a separate category. So, it will be interesting to see how the emergence of this new field effects drug development and approval in future years.
But what about the price? Since a majority of drugs that received the green light in 2017 were for rare diseases and cancer, and these target relatively small populations, this can cost hundreds of thousands of dollars for patients to purchase the medicine. Not only are patient advocates concerned, but there is some worry among drug makers on price as well. For example, two medicines approved this year for diabetes entered an already crowded market so this competition gives insurers leeway to drive down prices significantly. This is projected to drive down returns in the top 12 drug makers at an eight year low.
For a complete list of drug approvals, click here. How do you think the trend for 2018 drug approvals will go? We’d love to hear your feedback. Please comment below.