FDA Novel Drug Approvals: February 2022
This article reviews the novel drugs approved by the FDA in February 2022. together with Dr. Naveed Yasin, Dr. Vinicius Texeira, and Dr. Jennifer Huen Three novel molecules were approved in February 2022: Small molecules: Large molecule: We recently covered mitapivat, the allosteric pyruvate kinase activator. Pacritinib has had a long clinical journey, which included…
Mitapivat, a First-in-Class Allosteric Pyruvate Kinase Activator
The FDA recently approved Agios’ Pyrukynd (mitapivat, AG-348), a first-in-class, allosteric activator of pyruvate kinase (PK), for treatment of hemolytic anemia in adults with the genetic condition, pyruvate kinase deficiency. The drug is given orally with a starting dose of 5 mg BID, titrating up to 50 mg BID depending on hemoglobin (Hb) levels. See…
2021 Oncology FDA Approvals: Small Molecules Deep Dive
together with Dr. Jennifer Huen, Saumil Patel, and Dr. Naveed Yasin In 2021, the FDA approved 9 non-radiological novel small molecule drugs for oncology. Excluding melphalan flufenamide, which has already been withdrawn, the remaining FDA-approved novel small molecule oncology drugs of 2021 are: umbralisib (PI3Kδ and CK1ε inhibitor) sotorasib (KRASG12C inhibitor) infigratinib (FGFR1/2/3 inhibitor) tepotinib…
2021 First-in-Class Small Molecule Drugs
together with Dr. Naveed Yasin, Dr. Jennifer Huen, Dr. Vinicius Texeira, and Dr. Adrian Parodi In 2021 there were: 50 novel drugs approved by the FDA 27 that CDER considers first-in-class (FIC) 16 first-in-class small molecules (according to CDER) These drugs are the first in their therapeutic class to have a particular mechanism of action.…
FDA Novel Drug Approvals – Jan. 2022
together with Dr. Naveed Yasin, Dr. Jen Huen, and Dr. Adrian Parodi There were four novel drugs approved by the FDA in January 2022 (2 small molecules, 2 large molecules). The novel January 2022 new drug approvals appear below in this Drug Hunter minireview: See our overview of all 36 of the novel small molecule…