FDA to review Lev’s Cinryze application
WASHINGTON The Food and Drug Administration’s Blood Products Advisory Committee will review Lev Pharmaceuticals’ biologics license application for Cinryze, for both acute and prophylactic treatment of hereditary angioedema on May 2.
Lev said it is preparing responses to questions the FDA posed in a Jan. 30 complete response letter.
In the letter, the FDA requests information on chemistry, manufacturing and controls, as well as additional analyses of existing efficacy data from clinical trials of Cinryze. So far, the agency has not asked for additional safety information or clinical trials.
New combination of drugs shown favorable in treating lupus
NEW YORK A new study suggests that a combination of two potent drugs may serve as a new treatment for those who don’t respond to conventional Lupus treatments.
In the study, Ronald van Vollenhoven and colleagues at Karolinska University Hospital in Stockholm tested 16 female patients who did not respond to traditional lupus treatment, and were given, as a result, weekly infusions of rituximab for 4 weeks. The first and last infusions were combined with cyclophosphamide and a steroid, according to published reports.
It was found that after 6 months there was a significant decrease of SLE severity also known as systemic lupus erythematosus, which is an autoimmune disorder that damages the joints, kidneys, heart, lungs and blood.
Researchers noted that the presence of rituximab which targets B cells of the immune system, and cyclophsophamide, a strong immune suppressant drug, showed 50 percent improvement in disease severity, as well as causing the disease to go to remission in nine out of the thirteen patients.
Amgen, Roche battle over Mircera still unsettled
In the long battle for Amgen to prevent generic drug company Roche Holdings from bringing its anemia drug Mircera into the US market, a federal appeals court has ruled that Roche could import its drug as long as it was not for sale, while also returning the case back to the International Trade Commission.
Amgen feels that since Roche applied for Mircera’s approval from the FDA, it was violating Amgen’s patents—for Epogen and Aranesp—because the application proved intent to sell. The FDA has already approved the drug but, according to published reports, it has not been marketed it in the US based on the legal matters involved.
As Drug Store News reported yesterday, Roche agreed to the U.S. District Court for Massachusetts’ conditions in an attempt to get Mircera on the market, including, according to published reports, paying Amgen a higher royalty fee. The court’s approval would give Amgen a new rival in the top selling Anemia market, which has made up more than 40 percent of Amgen’s revenue per year. Roche has agreed to set Mircera’s price at or below Epogen’s for the remainder of the patents that Amgen holds.
Amgen’s patents for its anemia drugs begin expiring in 2013, and, according to reports, Roche plans on waiting until then to sell its drug in the U.S. According to IMS Health, Aranesp had U.S. sales of $3.2 billion last year and Epogen had sales of $3.1 billion.