Actavis subsidiary seeks approval for generic version of NuvaRing
DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.
Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck’s NuvaRing.
In response to the filing, Merck and Dohme B.V. filed a patent-infringement lawsuit against Warner Chilcott Tuesday in the U.S. District Court for the District of Delaware in an effort to prevent the generic product from being marketed; the lawsuit puts an automatic stay of FDA approval on the generic for 30 months, unless the companies settle the matter sooner.
NuvaRing had sales of about $560 million during the 12-month period that ended in October, according to IMS Health.
Actavis contraceptive patch doesn’t win FDA approval
DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.
Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.
The FDA is requesting more data on the difference between the patch used in the clinical trial and the one Actavis intends to market, which is a different size and formulation, the company said.
Biogen Idec drugs could advance treatment of hemophilia, clinical trials find
NEW YORK — Two experimental drugs under development by Biogen Idec are effective in reducing bleeding episodes in patients with two forms of hemophilia when administered as a preventive treatment, while also reducing the need for frequent injections, according to late-stage clinical trial data.
The two phase-3 studies were published in the November issue of the journal Blood and the December issue of the New England Journal of Medicine. The Blood trial, titled "A-LONG," tested Biogen Idec’s recombinant factor VIII Fc fusion protein in patients with hemophilia A, while the NEJM trial, titled "B-LONG", tested recombinant factor IX Fc fusion protein in patients with hemophilia B.
"Results from these largest global phase-3 pivotal trials demonstrate the potential of revolutionizing the hemophilia treatment paradigm by offering longer protection from bleeding episodes while reducing the frequency of intravenous injections," clinical lead Alvin Luk told DSN.
The hemophilia A trial divided 165 patients into three groups, one of which received a dose of the drug every 3-5 days per week on a preventive basis, known as prophylaxis; another prophylaxis group that received a dose every week; and another that received the drug on an as-needed basis as bleeding episodes were occurring. Any patients in any group could use the drug for major surgeries. Patients who received prophylaxis had significantly reduced bleeding rates compared with those who received it on an episodic basis.
The 123 hemophilia B patients were divided into a group that received the weekly prophylaxis; a second group that received interval-adjusted prophylaxis every 10 days or longer; a third group that received treatment as needed; and a fourth that received it for surgical procedures. In the first, second and third groups, 90.4% of bleeding episodes were resolved after one injection, and the responses were good or excellent among patients undergoing surgery.