Most FDA decisions scheduled for September yielded positive results, but there were also isolated disappointments. Seven new molecular entities, or NMEs, were approved during the month, bringing the total number of NME approvals for the year to 24. This is far fewer than the 40 approvals received at the same time last year.
NMEs are considered a measure of innovation in drug discovery because they contain active ingredients or ingredients that have not previously been approved by the Food and Drug Administration.
Among the positive judgments Bluebird Bio, Inc BLUE $3 million Skysona gene therapy approved for the treatment of a rare neurodegenerative disease in boys and Amylyx Pharmaceuticals, Inc. AMLX scored a win for his treatment for amyotrophic sclerosis Revance Therapeutics, Inc RVNC Botox rival Daxxify has been approved to treat frown lines.
Spectrum Pharmaceuticals, Inc. SPPI had a mixed month since his rolvedon was approved for the treatment of chemotherapy-induced neutropenia but it is Lung cancer drug failed to receive FDA panel endorsement
Here are the key PDUFA dates scheduled for October:
Will Theratech get a win for a more convenient formulation of its HIV drug?
Company: Theratechnologies, Inc. THTX
Type of application: supplementary biological authorization application
Candidate: Trogarzo
Indication: HIV-1
Date: 3 Oct
In the fourth quarter of 2021, the Company submitted the sBLA for the intravenous push route of administration of its Trogarzo for the treatment of human immunodeficiency virus type 1, or HIV-1. Trogarzo was first approved by the FDA in March 2018 for the treatment of adult patients with multidrug-resistant HIV. In the quarter ended May 31, the drug generated sales of $7.852 million for Theratech.
Alnylam on course to snag label expansion for Oxlumo?
Company: Alnylam, Inc. ALNY
Type of application: complementary new drug application
Candidate: Oxlumo
Indication: Hyperoxaluria type 1
Date: 6 Oct
Oxlumo, known by its generic name Lumasiran, an RNAi therapeutic, is being used for…
