White House drug pricing pact targets Medicaid as UniQure seeks FDA nod for Huntington's gene therapy
The administration's new drug pricing agreements mainly affect Medicaid, while UniQure has filed for accelerated approval of its Huntington's gene therapy with the FDA and the UK regulator.
The White House finalized a series of drug pricing agreements this week that chiefly apply to Medicaid, the U.S. program mandated to obtain the lowest drug prices, while leaving Medicare outside the mandatory cuts under discussion. Observers suggest the short-term effect on overall drug costs could be modest. In a separate development, UniQure disclosed that it has placed its experimental gene therapy for Huntington's disease before the Food and Drug Administration for accelerated approval review.
This move follows a June reversal by the FDA, which had previously told the company it could not submit the therapy based on its Phase 1/2 trial data showing a slowdown in disease progression. UniQure also submitted the same therapy to the United Kingdom's regulatory agency, seeking approval on both sides of the Atlantic.
Why it matters
The deals could reshape drug pricing for millions on Medicaid, and UniQure's filing may bring a novel treatment closer to patients with Huntington's disease.
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