Shots:

• The US FDA has placed a clinical hold on the use of lenacapavir in borosilicate vials in an ongoing 10 clinical studies i.e., 5 P-I, 2 P-II & 3 P-III studies for the treatment of HIV and HIV PrEP
• The pause is due to concerns about the compatibility of the vial type made of borosilicate glass with lenacapavir solution which leads to the formation of sub-visible glass particles in the solution of lenacapavir
• Additionally, the company continues the dosing of oral formulations & other study activities, including the monitoring and the dosing of participants. Lenacapavir is an HIV-1 capsid inhibitor for the prevention of HIV-1 infection

Ref: Businesswire | Image:Gilead