Horizon Pharma Provides Update FDA Joint Advisory Committee Meeting

(RTTNews) - Horizon Pharma Inc. (HZNP), Tuesday said that the FDA joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee was split on whether the data show adequate differences in cardiovascular risk among a gastroprotective nonsteroidal anti-inflammatory drugs or NSAIDs to support labeling change for NSAIDs due to cardiovascular risk.

The committee found that there was not enough data at this time to differentiate among the NSAIDs. The FDA will take the committee's discussion into consideration and will make the final determination in this matter.

"Recognizing that individuals respond differently to NSAIDs, we make available two prescription strength NSAID options, VIMOVO and DUEXIS, both of which have demonstrated a significant reduction in gastrointestinal ulcers, allowing prescribers the ability to treat a broad range of arthritis patients," said Timothy Walbert, chairman, president and chief executive officer, Horizon Pharma.