Gilead Again Seeks HIV Drug Approval From FDA After Addressing Vial Compatibility Issues

Gilead Sciences GILD resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection.

Earlier, in the month of February, 2022, the regulatory agency has issued a complete response letter, indicating Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials.

The company said that the NDA resubmission addressed issues related to vial compatibility.

Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, said, “There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes. We are committed to addressing unmet needs and recognize the urgency for filling the critical treatment gap for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy."

The FDA is expected to establish a new Prescription Drug User Fee Act (PDUFA) date, once the New Drug Application (NDA) is accepted for review.

Gilead Shares are trading low at $62.50 during after hour session.

Posted In: NDA ResubmissionBiotechNewsHealth CareFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.