June 25, 2024

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FDA lifts clinical hold on Gilead’s HIV drug Lenacapavir

FDA lifts clinical hold on Gilead’s HIV drug Lenacapavir


FDA lifts clinical hold on Gilead’s HIV drug Lenacapavir. 

A few days ago, Gilead said that the FDA has announced that its clinical trials of Lenacapavir for HIV treatment and pre-exposure prophylaxis will resume.


As early as last December, the FDA first suspended clinical trials related to Gilead’s injectable HIV drug candidate Lenacapavir. 


FDA lifts clinical hold on Gilead's HIV drug Lenacapavir


In response, in March this year, the US FDA issued a complete response letter (CRL) for Gilead’s HIV drug Lenacapavir marketing application. In the CRL, the FDA identified chemical manufacturing control (CMC) issues related to the compatibility of Lenacapavir injection with the intended glass vial.

The FDA has raised questions about the compatibility of borosilicate glass vials with Lenacapavir injection, an issue that has led to the suspension of at least 10 clinical trials of Lenacapavir injection. 


After receiving the CRL, Gilead said it will provide the FDA with plans and data on the use of different types of vials.

At the time, Baird & Co. analysts wrote in a note to clients that the launch of Lenacapavir could be delayed by a year due to the FDA decision.


For Gilead, Lenacapavir has been one of its blockbuster drugs. The drug is a long-acting HIV-1 capsid inhibitor that inhibits HIV-1 replication by interfering with multiple important steps in the viral life cycle, including capsid-mediated uptake of HIV-1 proviral DNA, viral Assembly and release and formation of the capsid core have received FDA breakthrough therapy designation.

If approved, it would be the only HIV treatment to be administered twice a year, much less frequently than currently available drugs.


Earlier, investment bank Mizuho Securities said industry analysts agreed that Lenacapavir sales could exceed $1.1 billion by 2030.


Now, the FDA has removed its clinical hold after reviewing Gilead’s bid to store the drug in an alternative vial made of aluminosilicate glass. Gilead said it will work with investigators at the study site to fully resume the Lenacapavir development project as soon as possible.








Reference source:

1. Gilead HIV prospect escapes FDA hold after glass compatibility glitch triggered regulatory setbacks

2. Once Medicine “Another HIV drug clinical study was suspended by the US FDA, this time from Gilead”

3. Once medicine “Gilead HIV drug Lenacapavir was rejected by the US FDA for approval”

FDA lifts clinical hold on Gilead’s HIV drug Lenacapavir

(source:internet, reference only)

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