Bristol-Myers Squibb Company
) 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
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,
), went off patent in the US in May 2012. The drug's
genericization has resulted in the loss of significant revenues
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
) appears to be more favorably placed in the large cap pharma
space with a Zacks Rank # 2 (Buy). Meanwhile,
) too carries a Zacks Rank # 2.
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