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FDA Approves Sarepta Duchenne Drug in Shocking Reversal

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Glad Friday, readers.

In 2016, biotech Sarepta Therapeutics made waves when the Meals and Drug Management (FDA) rebuked its personal clinical advisers’ evaluations and licensed the company’s pioneering drug for Duchenne muscular dystrophy, a unprecedented muscle-wasting dysfunction that may go away sufferers lifeless by way of their mid-20s.

It used to be déjà vu everywhere once more this week because the company inexperienced lit Sarepta’s Vyondys 53—lower than six months after declining an approval in line with toxicity and protection issues. Sarepta inventory rocketed up greater than 31% on Friday following the verdict.

It is a difficult and private factor that has, now and then, pitted affected person advocates and individuals of the clinical neighborhood in opposition to each and every different.

For some context: Exondys 51, the primary Sarepta muscular dystrophy drug cleared by way of the FDA, used to be extremely polarizing. An impartial panel voted in opposition to recommending the drug’s approval in a 7-6 vote again in 2016—however a concerted marketing campaign by way of sure affected person teams perceived to have shifted the facility dynamic and resulted in the drug’s eventual approval.

In step with Reuters, the FDA says that it had “regarded as the prospective dangers related to the drug, the life-threatening and debilitating nature of the illness, and the loss of to be had remedy” in its choice to approve Vyondys 53.

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It is going to turn how tough it may be to stability the hopes of affected person communities with the FDA’s requirements. The regulators have a twin mandate of balancing protection and efficacy. However a well-designed affected person motion can sway what occurs, too—and that may have far-reaching implications for quite a few different therapies.

Learn on for the day’s information, and feature a phenomenal weekend.

Sy Mukherjee
sayak.mukherjee@fortune.com
@the_sy_guy


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