New molecular entities had a rough week at the US FDA, as the agency issued a complete response letter for Gilead Sciences, Inc.’s bulevirtide for hepatitis delta virus infection, CytoDyn, Inc. withdrew its BLA for leronlimab in multi-drug resistant HIV, and FDA action on Amicus Therapeutics, Inc.’s cipaglucosidase alfa was deferred due to COVID-19 lockdowns in China.
Clearing the agency, on the other hand, were a pediatric claim for another Gilead antiviral, Vemlidy (tenofovir alafenamide) to treat patients 12 years and older with chronic hepatitis B with...