The first months of 2017 proves to be successful again for the approval of new drugs. Indeed, the FDA has already cleared 21 new prescription medicines for sale against 22 in the whole of 2016, and just nine at this stage last year.
The EMA has recommended 42 compared with a 2016 total of 81, and 31 in the first five months of last year. Unlike the FDA, the EMA includes generic or non-patented drugs in its list.
According to John LaMattina, a former research head for Pfizer and a board member at PureTech Health, :“A lot of biopharmaceutical companies are filling their pipelines with programs that seek treatments for diseases that can be approved with an accelerated review such as rare diseases, different cancers and anti-infectives.” He carries on saying also “These types of programs benefit from requiring modest-sized clinical trials and have the potential for generous pricing. We’re seeing fewer R&D resources devoted to programs that require rigorous differentiation in Phase III trials.”
Basically, drugmakers have undestood that is better moving their resources for developing medicines for more specialist and higher-priced therapies rather than mass-market products.
Eveni if also big pharma companies can be in trouble when it comes to getting a decent return on the billions of dollars they spend each year on R&D, this year looks good for them as theirshighly promising products are being forecasted to generate billions of dollars in sales, according to consensus analyst forecasts compiled by Thomson Reuters.
- Dupixent , a treatment for severe eczema, from Sanofi and Regeneron- It could sell more than $5 billion by 2023;
- Ocrevus, Roche’s multiple sclerosis drug , with sales above $4 billion
- Durvalumab, AstraZeneca’s cancer drug durvalumab, forecast to generate nearly $3 billion
- Awaiting approval within this year, there are Novo Nordisk’s diabetes drug semaglutide, the novel cell therapy for leukemia from Novartis and a shingles vaccine from GlaxoSmithKline.
Another reason why approvals have been rising in the 2017, especially in U.S., could be according to Hilary Thomas, chief medical adviser at KPMG, the innovative approach of U.S. regulators that was helping to accelerate approvals, as it for the decision to clear a cancer drug for the first time based on genetics, not tumor location.
However the nature of many new medicine, so well targeted, means that a limited number patient population will get the latest wave of novel drugs, as she undelines in the interview with Reuters : “What the data masks is that while there might be more approvals, the total number of people getting new drugs is probably not going to up hugely because these are more specific, personalized treatments,” she said.