|Vertex Announces Update or INCIVEK® (telaprevir); Anacor Announces Positive Results of Tavaborole for Onychomycosis|
|By Staff and Wire Reports|
|Wednesday, 30 January 2013 00:38|
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.
Anacor Pharmaceuticals (ANAC) today announced positive preliminary results from the first of two Phase 3 trials of tavaborole, its topical anti-fungal for onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints.
In this first Phase 3 study (known as Study 301), 6.5% of patients treated with tavaborole met the primary endpoint of complete cure vs. 0.5% of patients treated with vehicle (p=0.001) at week 52. Complete cure is a composite endpoint that requires both a mycological cure and a completely clear nail.
Among the secondary endpoints, 26.1% of patients treated with tavaborole achieved a completely clear or almost clear (d10% clinical involvement) nail vs. 9.3% in the vehicle-treated arm (p<0.001) at week 52. 31.1% of patients treated with tavaborole achieved mycological cure vs. 7.2% in the vehicle-treated arm (p<0.001) at week 52. Mycological cure is the absence of fungus as determined by a negative potassium hydroxide (KOH) examination and a negative fungal culture. 15.3% of patients treated with tavaborole achieved completely clear or almost clear nail with mycological cure vs. 1.5% in the vehicle-treated arm (p<0.001) at week 52.
In addition to the primary and secondary endpoints noted above, 87.0% of patients treated with tavaborole had a negative fungal culture vs. 47.9% in the vehicle-treated arm (p<0.001) at week 52, and 24.6% of patients treated with tavaborole achieved completely clear or almost clear nail and negative culture vs. 5.7% in the vehicle-treated arm (p<0.001) at week 52.
We are pleased that tavaborole met all of the parameters outlined in our Special Protocol Assessment with the FDA with a high degree of statistical significance in this first Phase 3 trial. With its high rates of completely clear or almost clear nails, high negative culture rates, demonstrated safety and ease of use, we believe tavaborole could offer significant advantages over currently approved treatments for onychomycosis, said David Perry, Chief Executive Officer of Anacor.
Patients and physicians have been waiting for a safe and effective treatment for onychomycosis. Millions of patients are treated several times a year with debridement because it is the safest option to improve the appearance of the nail and minimize discomfort, even though debridement doesnt actually eliminate the fungus. Tavaborole has the potential to offer these patients an effective, safe and convenient therapy to treat this difficult infection and prevent it from spreading to other toes and skin, said Max Weisfeld, DPM.
Tavaborole belongs to a novel class of drugs, known as oxaboroles, and should be an exciting addition to dermatologists treatment options for patients who suffer from onychomycosis, said Boni Elewski, MD, Professor of Dermatology, University of Alabama. It is a challenging and frustrating disease, but tavaborole could be a safe and effective alternative for patients who are embarrassed by the appearance of their yellow, thickened nails and are either unwilling or unable to take oral medications to treat this condition.
Tavaborole Phase 3 Study 301 Design--Study 301 enrolled 594 patients in the United States and Mexico with distal subungual onychomycosis, randomized two-to-one to receive either tavaborole, 5% solution, or vehicle. Eligible patients were at least 18 years of age (with no upper age limit) with a clinical diagnosis of distal subungual onychomycosis involving 20% - 60% of the total area of the target great toenail, at least 3mm of clear nail from the proximal nail fold to the most proximal visible mycotic border and positive mycology. Patients were instructed to apply tavaborole solution or vehicle to the target great toenail once daily for 48 weeks.
Overall, tavaborole was safe and well-tolerated across study subjects. There were no serious adverse events related to study drug. The rate of discontinuations as a result of adverse events was low (2.8% for tavaborole and 1.6% for vehicle).
Study 301 is the first of two Phase 3 clinical trials of tavaborole in onychomycosis. Anacor received a Special Protocol Assessment from the FDA on all major parameters of the studies, including endpoints. Data from the second Phase 3 clinical trial (known as Study 302) are expected in March of this year. Study 302 is identical in design to Study 301 with sites in the United States and Canada. Subject to the results of Study 302, Anacor plans to file an NDA for tavaborole in the middle of this year.
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