Bristol-Myers Squibb Co. said Friday that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old.
The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds. The new approval expands the drug’s use to children age three months to three years who weigh at least 7.7 pounds.
The FDA also approved a new method for administering the drug, known as “capsule sprinkle,” for patients who cannot swallow drug capsules.
Bristol-Myers said it studied the safety and effectiveness of the drug in the younger group of patients for more than two years. Side effects reported in the study were similar to those reported in adult studies, except that skin rash was more common and severe among children.
Shares of Bristol-Myers Squibb Co. rose 19 cents to close at $40.20.
Filed Under: Drug Discovery
