Bristol-Myers Squibb Company (BMY) recently received positive news from the US Food and Drug Administration (:FDA) when the US regulatory authority approved the pharma major’s HIV drug Sustiva for treating children between three months and three years. The body weight of the children should not exceed 3.5 kilograms.
The approval provides a once-daily option as part of a regimen for HIV infected children between three months and three years. Moreover, the “capsule sprinkle” administration procedure is beneficial for children who cannot swallow capsules or tablets.
We note that Sustiva is already approved for treating HIV infected patients aged three years and above and weighing not less than 10 kilograms. The FDA decision has expanded the patient population for Sustiva. This will boost the drug’s sales potential.
The FDA decided to expand the patient population for Sustiva on the basis of data from three open-label studies, which evaluated the pharmacokinetics, safety and antiretroviral activity of the drug combined with other antiretroviral agents in 182 antiretroviral-naïve and – experienced patients infected with HIV. The studies evaluated patients aged between three months and 21 years for a median of 123 weeks.
The FDA’s decision to broaden Sustiva’s target population is encouraging for Bristol-Myers, which has entered a challenging phase following the genericization of Plavix. Plavix, co-developed with Sanofi (SNY), went off patent in the US in May 2012. The drug’s genericization has resulted in the loss of significant revenues for Bristol-Myers.
Bristol-Myers is looking to combat the challenges confronting it through partnering deals and acquisitions and introducing new products to augment its product portfolio.
Bristol-Myers, a large cap pharma stock, carries a Zacks Rank # 3 (Hold). AbbVie (ABBV) appears to be more favorably placed in the large cap pharma space with a Zacks Rank # 2 (Buy). Meanwhile, Celgene Corporation (CELG) too carries a Zacks Rank # 2.
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