The FDA Went on an Epic Drug Approval Binge This Week: Brainstorm…

Happy Friday, readers!

The Food and Drug Administration (FDA) isn’t resting on its laurels in the dog days of summer.

In the past week, the FDA has approved five novel new drugs to treat a slew of conditions from cancer to the skin disease psoriasis to tuberculosis (TB) to the sleep disorder narcolepsy. Two of the approvals were granted Wednesday; another one on Thursday; and then two more on Friday.

Here’s what they were, in chronological order: Pretomanid, a medicine for the most drug-resistant forms of TB that was created by the nonprofit TB Alliance and will be distributed by Mylan; Wakix, a new therapy from private firm Harmony Biosciences to treat excessive daytime sleepiness in narcolepsy patients (and reportedly the first drug of its kind to not be classified as a controlled substance by the DEA); Roche’s Rozlytrek, a personalized cancer treatment that is specific to genetics rather than a specific kind of tumor or cancer; Celgene’s Inrebic, a so-called “JAK inhibitor” approved for the bone marrow cancer myelofibrosis (and whose green light is a boon to drug giant Bristol-Myers Squibb, which is buying Celgene); and, finally, Rinvoq, a rheumatoid arthritis drug from biotech giant AbbVie which the company hopes will staunch bleeding sales of its nearly two-decade-old superstar Humira, which is still the world’s best-selling drug. AbbVie is currently in the process of buying Botox maker Allergan in its own mega-deal.

It should be noted that the latter two treatments from Celgene and AbbVie are part of a class that come with some notable adverse events and black box warnings. Still, they could prove an improvement to certain patients.

All told, the FDA has now approved 23 new treatments to date this year. And this is now a multi-year trend with the agency, which appears eager to get as many new treatments (branded, generic, or otherwise) onto the market as soon as possible. (How efficacious and cost-effective those treatments are, of course, is a more complicated discussion.)

Read on for the day’s news, and have a wonderful weekend.

Sy Mukherjee, @the_sy_guy, [email protected]

DIGITAL HEALTH

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