Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir

Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir.

The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral drugs.

In February, the FDA denied the approval of lenacapavir after concluding that the borosilicate glass vials containing the drug were incompatible with the medication as they could result in contamination with “sub-visible” glass particles.

Late last year, FDA placed a clinical hold on the use of the drug candidate in borosilicate vials for ongoing studies.

Foster City, California-based Gilead has also studied oral formulations of the drug.

Gilead included data on the drug used in vials made from aluminosilicate glass in its most recent new drug applicat…

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Injectable anti-HIV therapies could see strong growth

Photo by Miguel Á. Padriñán from Pexels

The market for injectable anti-HIV therapeutics will be worth $28 billion by 2029, according to projections from the analyst and consulting firm GlobalData. 

GlobalData valued the broader HIV therapeutics market at $22.9 billion in 2019 across the U.S., France, Germany, Italy, Spain, U.K. and Japan. 

While the overall market is growing at a low single-digit rate, injectable therapies will likely see more brisk growth, GlobalData projects. 

To date, the majority of HIV therapies are orally-delivered antiretroviral drugs although a handful of injectable drugs have hit been introduced over the years. 

Future injectable anti-HIV therapies could be administered less frequently than oral drugs. 

One early injectable anti-HIV therapy, Fuzeon (enfuvirtide) from Roche (OTCMKTS:RHHBY), is administered multiple times per day, posing a challenge for adh…

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