FDA Novel Drug Approvals: March 2022

This article reviews the three novel drugs approved by the FDA in March 2022 in detail.

together with Dr. Naveed Yasin, Jesse Keicher, Dr. Jennifer Huen, and Dr. Adrian Parodi

Small molecules:

  1. Ztalmy® (ganaxolone): An oral GABAA receptor positive allosteric modulator to treat seizures in cyclin-dependent kinase-like 5 deficiency disorder. 
  2. PluvictoTM (lutetium Lu 177 vipivotide tetraxetan): A therapeutically active, injectable radioligand to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies

Large molecule:

  1. OpdualagTM (relatlimab and nivolumab): Relatlimab is the novel component (a Lag-3 blocking antibody). The combination is approved to treat unresectable or metastatic melanoma

Some interesting snippets about each drug from our report:

  • Unlike recently approved brexanolone, ganaxolone has a long half-life (34 h) and can be given orally. Since it does not form GABAA-inhibiting metabolites as brexanolone does, it can also be used to treat seizures.
  • Most recognize the target of Pluctivo as PSMA (prostate-specific membrane antigen) a famous marker for prostate cancer. It’s also known as glutamate carboxypeptidase II, catalyzing the hydrolysis of N-acetylaspartylglutamate, hence the peptidic nature of the drug ligand.
  • Relatlimab targets Lag-3, making Lag-3 the third immune checkpoint mechanism with an approved drug molecule (after CTLA-4 and PD-1/PD-L1). TIGIT was widely anticipated to be the next immune checkpoint to be approved until disappointing Ph. III SKYSCRAPER-02 results were recently disclosed by Roche.

The full Premium report below summarizes for each drug:

  • Key endpoints
  • Disease context
  • Biological mechanism of action
  • Pharmaceutical properties
  • Prior treatment options
  • Differentiation
  • Commercial, regulatory, and industry context

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  • …and hundreds of others