New Molecular Entity Approvals: FDA OKs Two Merck & Co.’s HIV Drugs
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The US Food and Drug Administration (FDA) has approved Merck & Co.’s two new HIV-1 medicines: Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and Pifeltro (doravirine, 100 mg), a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. Delstrigo and Pifeltro both contain the new active ingredient, doravirine.

Both Delstrigo and Pifeltro are indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. Delstrigo contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection.

Several other new molecular entities (NMEs) were approved by the FDA in late August: Diacomit (stiripentol), a drug to treat seizures in certain patients, Oxervate (cenegermin-bkbj), a drug to treat a degenerative disease of the cornea, and Takhzyro (lanadelumab), a drug to treat hereditary angioedema.

Source: Merck & Co.

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