Viatris Inc. ( VTRS Quick Quote VTRS - Free Report) obtained the FDA’s tentative approval for a new drug application for a fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.
Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors and an integrase strand transfer inhibitor.
The triple combination was approved in the United States in March 2022 under the brand name Triumeq PD.
The fixed-dose combination of abacavir/dolutegravir/lamivudine is approved for once-daily treatment of pediatric patients weighing at least 6 kg up to 25 kg, with HIV-1 infection and the recommended dose of the combination for oral suspension is determined as per the patient’s weight.
The approval of this single-tablet regimen — the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg — is expected to reduce the pill burden for children living with HIV.
The FDA's tentative approval came through the President's Emergency Plan for AIDS Relief program. It implies that the formulation meets all the agency's quality, safety and efficacy standards. Viatris has signed a licensing agreement for pediatric dolutegravir from the Medicines Patent Pool (MPP) and a development agreement with ViiV Healthcare and the Clinton Health Access Initiative for producing and distributing the fixed-dose combination of abacavir/ dolutegravir/lamivudine.
ViiV Healthcare, the global HIV specialist company, is majorly-owned by GSK, with Pfizer and Shionogi B.V. as shareholders.
The World Health Organization recommends this fixed-dose combination as a preferred first-line regimen for pediatric patients.
HIV treatment coverage for children and adolescents lags behind adults and approximately 660,000 children living with HIV did not receive antiretroviral (ARV) therapy in 2022. This approval supports Viatris’ sustainability goal to provide ARV therapy equivalent to a total of 30 million patients, including more than 2 million children living with HIV/AIDS, between 2022 and the end of 2025.
Viatris’ stock has lost 3.1% so far this year compared with the
industry’s decline of 9.5%. Image Source: Zacks Investment Research
VTRS is a leading producer of active pharmaceutical ingredient used in generic ARVs, which treat HIV/AIDS. The company has a few licensing agreements with MPP for HIV. For ARV and infectious disease products, it also has license agreements with Gilead, Merck, TB Alliance and Otsuka.
Viatris reported better-than-expected results for the second quarter. The company plans to divest some of its businesses later in 2023, which should allow it to better focus on its core businesses.
The company is looking to broaden its portfolio.
Earlier, Viatris and Mapi Pharma Ltd. announced that the FDA accepted the collaboratively submitted new drug application for GA Depot 40 mg for review.
The product is a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis. The regulatory body has assigned a target action date of Mar 8, 2024.
Zacks Rank & Stocks to Consider
Viatris currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are
Dynavax Technologies ( DVAX Quick Quote DVAX - Free Report) and Exelixis ( EXEL Quick Quote EXEL - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 51 cents, while the earnings estimate for 2024 is currently pegged at 2 cents per share.
Shares of EXEL have gained 41.8% year to date. Earnings estimates for 2023 have risen by 9 cents in the past 60 days to 98 cents.