|Vertex Reports Update to US Prescribing Info for INCIVEK; Endo Offers Comment on Dismissal of Suit Against FDA|
|By Staff and Wire Reports|
|Wednesday, 19 December 2012 20:12|
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified.
Rash and serious skin reactions are known adverse events associated with INCIVEK combination treatment and were previously included in the warnings and precautions section of the label. Given the severity of the events reported in the post-marketing setting, and the importance of discontinuing INCIVEK combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning.
“The safety of people taking our medicines is our first priority, and we are committed to ensuring that patients and physicians are aware of the label update to help them use INCIVEK properly,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “We will continue to educate physicians to follow the rash management plan developed while INCIVEK was in clinical trials and the information contained in the updated label.”
In Phase 3 clinical trials, less than 1 percent of people who received INCIVEK combination treatment experienced a serious skin reaction. These serious skin reactions required hospitalization and all patients recovered. For serious skin reactions, INCIVEK combination treatment must be discontinued immediately, and patients should be promptly referred for urgent medical care.
The INCIVEK label was also updated to include additional information on the time to onset and management of anemia.
Endo Health Solutions Inc. (Nasdaq: ENDP) announced U.S. District Judge Reggie B. Walton, of the U.S. District Court for the District of Columbia, dismissed the case of Endo's subsidiary, Endo Pharmaceuticals Inc., against the U.S. Food and Drug Administration (FDA). Endo Pharmaceuticals argued that FDA failed to meet its legal obligation to determine in a timely manner whether the original formulation of OPANA ER was withdrawn from the market for reasons of safety. The judge ruled against Endo, noting that he believes the FDA has not unduly delayed making a determination on the matter. The FDA stated that it intends to make its determination by May 2013.
Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. The ruling by the court now allows for a generic non-tamper resistant version to enter the market on Jan. 2, 2013.
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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment.