Ravicti’s price tag is $250,000 to $290,000 per year while the upper WAC price for Valeant’s competing product Buphenyl is roughly $240,000 at the maximum dose; Hyperion has option to acquire Buphenyl.
Hyperion Therapeutics Inc. is preparing to launch its first product, Ravicti (glycerol phenylbutyrate), for management of rare disorders in which ammonia builds up in the body. But it is uncertain whether payers will be willing to pay as much as $50,000 more for the drug than the competing treatment since its advantage is convenience and tolerability.
FDA approved Ravicti on Feb
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
