FDA Drug Approvals up Sharply in Q1

24.04.2017 -

After a major slowdown in 2016, new drug approvals by the US Food and Drug Administration rose sharply in the first quarter of 2017, according to a report by EP Vantage. Up to mid-April, the authority had approved more new drugs than during the same quarter of during the past six years.

The 12-drug list compares with only 22 new medical entities greenlighted in 2016. Observers said, however, that it will be hard for approvals to continue at that pace throughout the year. Figures for the full years 2014 and 2015 were 41 and 45 respectively.

One of the most promising on the list, in terms of potential 2022 sales, is said to be Roche’s multiple sclerosis drug Ocrevus (ocrelizumab). In clinical trials, it beat out the standard therapy for treating the relapsing / remitting form of the disease, Merck KGAa’s Rebif, according to the analysis website, and also posted positive data in patients with the primary progressive form of the disease. Ocrevus is said to be priced at a discount to counter the trend toward rising MS drug prices. Nevertheless, it is seen as having sales of $4.1 billion by 2022.

Another included among those with top potential is Sanofi and Regeneron’s atopic dermatitis treatment Dupixent (dupilumab), the first approved drug to inhibit the IL-4 and IL-13 immune system pathways, and the first new treatment in years for atopic dermatitis, a potentially debilitating form of eczema, The drug is planned to be launched at a price of $37,000, and carries has a 2022 sales estimate of$4.1 billion. Sanofi and Regeneron are currently embroiled in a patent dispute with Amgen.

Novo Nordisk’s new weekly GLP-1 diabetes drug semaglutide, which showed potential to cut the combined risk of heart attack, stroke, and cardiovascular death by 26% in a study released in September 2016, is expected to post 2022 sales ranging up to $2.2 billion Tesaro’s Zejula (niraparib) ovarian cancer treatment, a PARP inhibiter, is forecast to have sale of $1.9 billion in five years. 

Other new drugs approved in the first three months of this year include products to treat opioid-induced constipation, metastatic Merkel cell carcinoma, Parkinson’s disease, advanced breast cancer in postmenopausal women, carcinoid syndrome diarrhea, moderate-to-severe plaque psoriasis, Duchenne muscular dystrophy, secondary hyperparathyroidism and chronic idiopathic constipation.