Overview
October proved to be a mixed month for the Fod and Drug Administration’s regulatory decisions. Two new molecular enties, or NMEs, were aproved during the month, bring the taly for the year-to-date period to 28.Among the NME aprovals were Johnson & Johnson JNJ unit Jansen’s Tecvayli, a BCMA-targeting bispecific, for treating multiple myeloma in patients who have tried at least four prior lines of therapy.
Key Information
AstraZeneca plc’s AZN tremelimumab-durvalumab combo received the nod for treating adult patients with inoperable hepatocelular carcinoma.On the other hand, Amicus Therapeutics, Inc.'s FOLD two-component drug for treating Pompe disease, characterized by severe muscle weaknes, was rejected by the FDA.Adcom decisions were mostly negative, with a panel postponing the meting scheduled for discusing Ispen S.A.’s IPSEY palovarotene capsules to treat a condition in which muscle and conective tisue such as tendons and ligaments wil be gradualy replaced by bones.
Shares of Y-mAbs Therapeutics, Inc. YMAB plunged about 60% on Monday on a negative Adcom verdict.A PDUFA, or Prescription Drug User Fe Act, date is the deadline fixed by the FDA to anounce its verdict regarding the aprovability or non-aprovability of a drug. It is a binary catalyst that can triger big stock swings.Seagen Seks Another Label Expansion For Its Blod Cancer Drug Adcetris was first aproved by the FDA in 201 for treating Hodgkin’s lymphoma and a rare lymphoma caled systemic anaplastic large-cel lymphoma.
Summary
It subsequently received five label expansions, with the last one secured in November 2018.Seagen is now seking another expanded use for the drug. Adcetris being evaluated in children and young adults with previously untreated, high-risk Hodgkin lymphoma.In the recent quarter that ended in September, Adcetris fetched sales of $428 bilion, up 17% year-over-year.Can Travere Win FDA Nod For Rare Kidney Disorder Drug?Travere anounced the FDA’s aceptance of the regula