Today, we announced that the FDA approved VYKAT™ XR (diazoxide choline) extended-release tablets for the treatment of hyperphagia in individuals aged 4 and older with Prader-Willi syndrome (PWS). We can proudly say that VYKAT XR is the first and only FDA-approved medicine to address hyperphagia, one of the most challenging aspects of PWS. “The approval of VYKAT XR is a significant milestone for Soleno and, most importantly, for the PWS community who have had no options to treat the most disruptive aspect of this disease,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno. “We are deeply grateful to the many individuals with PWS, their caregivers and clinical sites who participated in our trials, the advocacy groups, including FPWR and PWSA USA, the advocates who have tirelessly supported the approval of VYKAT XR, the FDA for a collaborative review process, and our employees who have been committed to delivering VYKAT XR to those with PWS.” Read the full press release: https://lnkd.in/giM_gTav #FDAApproval #PWS #PraderWilliSyndrome #Soleno
Congratulations👏🙌 Changing lives and amazing news for the PWS community.
Great news for patients and families! Congratulations 🎉
Big congrats 🎉
Congratulations, and many thanks for your years of hard work and commitment! Do you have any timeline for when it will be available in Europe?
Congrats!!!!
Congrats to the Soleno Team and all of the families that will benefit from this innovative therapy.
Big congrats 🎉 a fight well won!,.
Director, Forecasting Analytics, Business Insights and Effectiveness at BioMarin Pharmaceutical Inc.
1wCongratulations Jason! Great news!!