US FDA approval tracker: February 2022

The last day of February brought FDA joy for Johnson & Johnson, Legend Biotech and CTI Biopharma but anguish for Gilead and Amryt. The latter's epidermolysis bullosa therapy, Oleogel-S10, was knocked back with the FDA requesting additional confirmatory evidence of efficacy, and it is not yet known whether Amryt will need to run another trial. Meanwhile, Gilead’s lenacapavir was turned down owing to vial compatibility issues; the drug had been filed in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. In December ten clinical studies, including Purpose-1 and 2 in pre-exposure prophylaxis, were put on hold due vial concerns. The long-acting HIV-1 capsid inhibitor is seen as an important pipeline asset for Gilead and was expected to be one of the biggest launches of 2022, but approval this year now looks very uncertain. J&J and Legend's Car-T agent, newly approved for multiple myeloma, is also slated as one of this year's biggest launches. The developers believe that last month's green light is only the beginning for Carvykti, and expect peak sales to reach at least $5bn, assuming success is achieved in earlier lines of therapy.