Novo Nordisk receives FDA approval for first-ever room-temperature stable hemophilia treatment
PRINCETON, N.J. Novo Nordisk’s NovoSeven RT, the first room-temperature stable recombinant drug for hemophiliacs with inhibitors, received approval from the Food and Drug Administration Tuesday.
NovoSeven RT is room-temperature stable, meaning that it remains stable at temperatures between 36 and 77 degrees and does not require refrigeration. NovoSeven RT’s also has a higher concentration so that infusions require almost half the amount of the original NovoSeven. It is the first room-temperature stable treatment for hemophiliacs with inhibitors not derived from plasma, thus eliminating the risk of viral transmission.
NovoSeven RT is a new formulation of NovoSeven, Novo Nordisk’s Coagulation Factor VIIa product designed for treatment of bleeding episodes in people with hemophilia A and B with inhibitors to Factor VIII and Factor IX and people with acquired hemophilia, as well as prevention of bleeding during surgery and invasive procedures. They are also used to treat patients with congenital Factor VII deficiency.
NovoSeven RT will become available in August.
Sanofi-Aventis, Debiopharm sue W.C. Heraeus over Eloxatin patent
BRIDGEWATER, N.J. Sanofi-Aventis and Debiopharm have filed a lawsuit in the U.S. District Court for the District of New Jersey against W.C. Heraeus, in which they accuse the company of helping generic drug makers infringe a patent on their active ingredient for the colorectal cancer drug Eloxatin.
In the suit, the plaintiffs claim that Heraeus manufactured the active pharmaceutical ingredient in Eloxatin for Mayne Pharma, Sandoz and Ebewe Pharma. The three companies independently submitted applications to sell generic versions of the drug before the 2013 expiration of the ‘874 patent.
Sanofi and Debiopharm have asked the court to issue a permanent injunction restraining Heraeus and its officers from selling and importing generic oxaliplatin products claimed in the patent into the U.S.
Currently, there are no FDA-approved generic versions of the drug, which had worldwide sales of $2.35 billion in 2007, according to Sanofi.
FutureScripts launches new Web site
PHILADELPHIA FutureScripts, a pharmacy benefit manager in Philadelphia, has unveiled a new website, www.futurescripts.com. The website is a tool for plan participants, health care professionals and benefit managers to help find key information about the drugs on FutureScripts’ formulary, how safe prescribing procedures work and much more.
“The new website allows our customers to find vital information about their medications—whether a drug is available as a generic and what that drug costs compared to similar medications,” said Paul Urick, senior vice president of FutureScripts. “Our website also provides health care professionals and plan participants the latest updates on the drugs on our formulary.”
Through the site, plan participants can find a participating pharmacy within the FutureScripts’ national network of more than 60,000 retail and specialty locations by ZIP code search or by entering a pharmacy name benefit managers can read about the latest pharmacy trends through the online FutureScripts InSight newsletter. The frequently asked questions section features the most common inquiries received by FutureScripts, ranging from ‘What is a 96-hour temporary supply?’ to ‘How do I request an exception to an age, gender, or quantity limit?’
“Overall, our new site was designed to service the needs of our customers and was developed in response to their suggestions,” said Urick. “We expect to further enhance and customize our website to fit the evolving needs of plan participants, employers, health care providers, and pharmacists.”