June 14, 2024

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FDA rejects Gilead new HIV drug: Lenacapavir

FDA rejects Gilead new HIV drug: Lenacapavir


FDA rejects Gilead new HIV drug: Lenacapavir.

Recently, the US FDA has 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.

Gilead said it intends to address this problem by providing a comprehensive plan and corresponding data on the use of different vials.


FDA rejects Gilead new HIV drug: lenacapavir

Picture from wikipedia.org


The launch of Lenacapavir could be delayed by a year due to the FDA decision, Baird & Co. analysts wrote in a note to clients. In a March 1 report, Baird analyst Brian Skorney wrote: “The CRL is not entirely surprising given the FDA’s previous concerns about sub-visible glass particles in vials of Lenacapavir borosilicate for injection. De is increasingly emphasizing the upside potential of the project…we believe this update will make it difficult for management to drum up enthusiasm for the project for the time being.”


Still, Skorney and his team believe the negative results are just a “minor setback” for Lenacapavir, which will eventually be approved by the FDA once Gilead resolves manufacturing and quality control issues.

Shares of Gilead were relatively unchanged Tuesday morning, likely reflecting investors’ readiness for an FDA rejection.


Gilead formally applied for FDA approval last summer after the company had positive results in a Phase 3 clinical trial. The trial tested people with multidrug-resistant (MDR) HIV-1 infection who had tried currently available treatments but were no longer effective.

In the trial, Lenacapavir was administered subcutaneously every 6 months in combination with an optimized background regimen.

Data show that Lenacapavir is potent in suppressing the virus, with approximately 80% of treated patients achieving an undetectable viral load (virological suppression, HIV-1 RNA <50 copies/mL) after 6 months of treatment .


The trial tested injectable and oral Lenacapavir, and data submitted to the FDA included an application for approval for each dosage form.

Gilead spokesman Brian Plummer noted that while the vial issue is specific to the injectable formulation, the oral tablet is used as part of the initiation of treatment.


“As such, for this filing, approval of Lenacapavir tablets is contingent on approval of Lenacapavir injection,” Plummer wrote in an email to BioPharma Dive.


For some time, the company has highlighted Lenacapavir as one of its most important drug programs. 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.


Unlike the HIV drugs on the market, Lenacapavir has a unique way of inhibiting the replication of the HIV virus, and, if approved, it will be the only HIV drug that can be administered every 6 months, compared to currently available drug treatments The frequency is much lower.


As a result, Wall Street has high expectations for Lenacapavir. Industry analysts agree that sales of the drug could exceed $1.1 billion by 2030, according to investment bank Mizuho Securities.






FDA rejects Gilead’s closely watched HIV drug

FDA rejects Gilead new HIV drug: Lenacapavir

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