After marquee HIV drug approvals last year for Gilead and GlaxoSmithKline, Merck will follow into the crowded market with two new meds. The drugmaker scored FDA approvals for a new non-nucleoside reverse transcriptase inhibitor called doravirine, both alone and in a combo with other HIV therapies.

Merck’s Delstrigo and Pifeltro won FDA approvals to treat adult patients with HIV-1 who haven’t had prior antiretroviral treatments, the company reports. Delstrigo, a combo of doravirine plus older HIV drugs from Glaxo’s ViiV Healthcare and Gilead, carries a boxed warning about risks of worsening hepatitis B infections. 

Pifeltro contains only doravine, and is to be administered with other antiretroviral drugs. Speaking on a recent conference call, Merck's president of global human health Adam Schechter said doravirine is a “near-term way for us to continue to be relevant in the market but a real growth opportunity as we bridge into the future with our pipeline.”  

Merck’s George Hanna, VP and therapeutic area head of infectious diseases, said in a statement the drugs “offer a compelling clinical profile for clinicians and people living with HIV.” The approvals come nearly two months ahead of the FDA's target action date; the drugs should be available within a month, Merck said.