The FDA recently approved a therapy originally approved in 1983, Vykat XR (diazoxide choline) from Soleno Therapeutics, based on a breakthrough indication for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). It is an oral medication in extended-release tablet form. Vykat XR is the first drug approved to treat hyperphagia.
Prader-Willi syndrome is a rare disease which leaves patients with low muscle tone, short stature and intellectual and developmental problems.
The Prader-Willi Syndrome Association USA estimates that the disorder occurs in 1 in every 15,000 live births, with more than 300,000 people worldwide affected. Soleno says that claims data show there are 10,000 PWS patients in the U.S
The company announced that, based on the average weight of patients in its clinical trials, Soleno will charge $466,200 per year for Vykat XR. The company expects it to launch in Q2. Panther Rare Rx has announced that it has been selected by Soleno to distribute Vykat XR
Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR
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