Bristol-Myers Squibb Announces FDA Priority Review for Videx Capsules

Strategic Insights -

A significant milestone has been reached in the fight against HIV as Bristol-Myers Squibb Co. has announced that the US FDA has granted a priority review for Videx capsules, a new medication that promises to simplify treatment regimens and reduce side effects. If approved, Videx capsules will be the first and only one-capsule, once-daily HIV drug available, revolutionizing the treatment of HIV. The new drug product contains enteric-coated beadlets designed to protect the essential medicine in Videx from degrading in the stomach, eliminating the need for a buffer that may contribute to gastrointestinal side effects.

Key Takeaways:

  • The FDA has granted a priority review for Videx capsules, a new medication for HIV treatment, which will be the first and only one-capsule, once-daily HIV drug available.
  • The new Videx capsules contain enteric-coated beadlets designed to protect the essential medicine in Videx from degrading in the stomach, eliminating the need for a buffer.
  • Bristol-Myers Squibb submitted the New Drug Application (NDA) for Videx capsules on January 31, 2000.
  • The FDA has set a goal to rule on the approvability of Videx capsules on or before July 31, 2000.
  • The FDA has indicated that priority review will be granted to agents that are considered to be significant therapeutic improvements in the treatment, diagnosis, or prevention of a disease.
  • Richard J. Lane, Bristol-Myers Squibb, stated that the company's goal is to help people with HIV simplify their drug regimens and increase adherence.
  • The company plans to continue developing new products that provide convenient options with fewer pills for people living with HIV.

Statistics:

  • Since 1992, the FDA has provided priority review for significant therapeutic improvements in the treatment, diagnosis, or prevention of a disease (1).
  • Bristol-Myers Squibb submitted the New Drug Application (NDA) for Videx capsules on January 31, 2000 (1).
  • The FDA has set a goal to rule on the approvability of Videx capsules on or before July 31, 2000 (1).

Sources:

  • (1) NewsRx.com, "Bristol-Myers Squibb Co.," "U.S. Food and Drug Administration."