The Food and Drug Administration (FDA) of the United States has now rejected for granting the approval for the investigational therapy ‘lenacapavir’ of Gilead Sciences for the treatment of the HIV.
The regulatory agency of the United States has also issued a complete response letter (CRL) to the NDA (New Drug Application) of the company for the lenacapavir that has been mentioning the issues of the CMC (Chemistry Manufacturing and Controls) related to the company’s compatibility along with the proposed container vial.
The investigational therapy ‘lenacapavir’ has been a long acting HIV-1 capsid inhibitor that has been developed for the purpose of treating the HIV-1 in the people of THE (heavily treatment-experienced) along with the multi-drug resistant or MDR infection.
In the past, the US FDA has also cited several issues regarding the vials made of the borosilicate glass and their compatibility along with the solution and has also placed the injectable therapy on the clinical hold. Merdad Parsey, chief medical officer of Gilead Sciences, the company has also been intending to provide the US FDA along with a comprehensive plan and also the corresponding data for using a different type of vial.
He also said, they are now looking forward for discussing further over the upcoming months so that, they can possibly make this new investigational new therapy that is available for the people living with the HIV as soon as possible.
