Merck granted FDA approval for HIV drugs

GlobalData has offered the view that although strong sales of the Doravirine-based HIV drugs can be expected, its unlikely they will achieve blockbuster status

Merck & Co has been granted FDA approval for two HIV drugs, Delstrigo and Pifeltro.

Thomas Moore, Senior Pharma Analyst at GlobalData, said: "This approval comes at a good time for Merck & Co, which will be looking to mitigate an anticipated drop in sales for its HIV portfolio due to an erosion of market share for the Atripla franchise due to competition from other drugs and the future launch of generics.”

“Although the combined sales of Delstrigo and Pifeltro are unlikely to match the highly successful Atripla, they are still expected to be well received by physicians, aided by the inclusion of treatment-naďve patients in yesterday’s FDA indication,” continued Moore.

A GlobalData report, PharmaPoint: Human Immunodeficiency Virus (HIV) – Global Drug Forecast and Market Analysis to 2025, forecasts the combined sales of these drugs to reach approximately $500 million across the US, France, Germany, Italy Spain, UK, and Japan (7MM) by 2023.

He said: “Of the two drugs, the fixed-dose combination therapy, Delstrigo, is expected to see the most success in terms of annual sales and is forecast to have peak 7MM annual sales of $369M in 2023, versus $144m in 2025 for Pifeltro. As a fixed-dose combination therapy, Delstrigo provides a more convenient dosing regimen to HIV patients, who are nearly always prescribed three-drug cocktails to keep the disease suppressed.”

“Merck have indicated that they will be pricing Delstrigo at $70 per day, while Pifeltro will be priced at $46 per day. This places Delstrigo at the lower end of three-drug combination therapies for HIV, which are typically priced at $70-80 per day. Merck will be hoping that this pricing strategy will give them a competitive edge compared to products from other companies in the HIV space, such as Gilead’s Genvoya and ViiV’s Triumeq, which are sold towards the top end of this price range,” Moore concluded.

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