After a big slowdown in 2016, FDA new drug approvals got off to a hot start in 2017. During the first quarter, the regulator signed off on more new meds than during the same period of any year in recent history.
So far this year, the agency has endorsed 14 new drugs, including blockbusters-to-be Ocrevus from Roche and Dupixent from partners Sanofi and Regeneron.
With 12 new drugs approved in the first quarter, FDA approval action this year bested any since 2011, according to the FDA’s website. In recent years, the agency has signed off on between 6 and 10 new drugs in the first quarter.
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Notable approvals this year are Roche’s multiple sclerosis med Ocrevus, which the drugmaker priced at a discount to “reverse the trend” of growing MS drug prices, and Sanofi and Regeneron’s atopic dermatitis med Dupixent. The pharma giants will now put their formidable sales forces behind the products, which are expected to be the biggest launches this year.
Another drug expected to make its U.S. debut with a 2017 FDA approval is PTC Therapeutics’ Emflaza, a decades-old steroid that’s been mired in a pricing scandal since Marathon Pharma ushered the med through the regulatory process. Facing pricing backlash thanks to an $89,000 sticker price, Marathon offloaded the drug to PTC, which hasn’t announced a new price.
It’ll be hard for the FDA to maintain the fast pace, as Regulatory Focus reports that the agency has about 20 new drug and biologics applications pending for the year, citing BioPharmCatalyst’s PDUFA calendar.
In addition to the approvals, there has been a notable denial. The agency turned away Eli Lilly’s much-anticipated rheumatoid arthritis med baricitinib last week, asking for additional clinical data to ensure appropriate dosing and safety. Baricitinib, a once-daily oral option for moderate-to-severe rheumatoid arthritis, is expected to reach $1.8 billion in sales by 2022.
The first-quarter uptick comes after approvals nosedived last year with just 22 meds given the green light. That compared to 2014 and 2015, when the FDA approved 41 and 45 new meds, respectively.