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3 days, 5 approvals-Celgene, AbbVie, Roche meds push FDA tally to 23 for the year

August 19, 2019 / Eric Sagonowsky

Lawmakers may have left the nations capital for summer vacation, but regulators at the FDA are staying busy. The agency churned out five approvals just last week from companies large and small and five more decisions are due by months end. Three of last weeks green lights opened the way for launches worth half a billion or more in annual sales. But the week started with a couple of OKs smaller on the sales side, if still significant for the organizations that developed them. Pretomanid, a tuberculosis med developed by the nonprofit TB Alliance, kicked things off Wednesday with an FDA nod in drug-resistant forms of the disease. On the same day, Philly-area pharma company Harmony Biosciences picked up its first FDA nod ever, passing agency gatekeepers with narcolepsy med Wakix. GlobalData pharma analyst Sarah Elsayed said she expects Wakix to pick up a “small share” of the $1.5 billion narcolepsy market. The drug is a “welcome addition” for doctors and patients, s...