FDA panel votes in favor of Pfizer kidney cancer drug
NEW YORK — A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.
Pfizer announced that the FDA’s Oncologic Drugs Advisory Committee voted unanimously to state that axitinib’s benefits outweighed its risks in patients with advanced renal cell carcinoma for whom first-line treatments had failed.
"We are pleased with the panel’s recommendation in support of axitinib for the treatment of previously treated advanced RCC, as additional therapeutic options are still needed for this patient population," Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said. "We look forward to continued discussions with the FDA as we take the next steps in the regulatory process for axitinib."
The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but takes them into account and usually makes its decisions in accordance with them.
Eli Lilly, Boehringer Ingelheim announce linagliptin trial results
INDIANAPOLIS — A drug currently under clinical development for Type 2 diabetes produced "meaningful" reductions in blood sugar, according to results of a late-stage clinical study.
Eli Lilly & Co. and Boehringer Ingelheim announced results of a 24-week, open-label arm of a phase-3 study of the investigational drug linagliptin combined with the generic drug metformin, presenting results at the International Diabetes Federation World Diabetes Conference in Dubai.
After 24 weeks, the companies said, patients with poorly controlled blood sugar showed HbA1C reductions of 3.7%. Most patients tolerated the drug well, with 9% experiencing adverse side effects and 1.5% reporting abnormally low blood sugar, also known as hypoglycemia.
"Many patients with high HbA1C levels require more than metformin alone to reach their blood glucose targets," Boehringer Ingelheim corporate SVP medicine Klaus Dugi said. "Linagliptin can support patients with Type 2 diabetes to effectively manage their condition in order [to] reach their blood-glucose targets."
In another study, patients who could not take metformin were given linagliptin or the generic drug glimepiride in a 34-week extension phase of a one-year trial. HbA1C levels in linagliptin patients remained stable between week 18 and week 52. Glimepiride showed similar levels of efficacy, but linagliptin produced fewer adverse side effects, the companies said.
NACDS supports anticounterfeiting legislation
ALEXANDRIA, Va. — New legislation proposed in the Senate would strengthen penalties against people who traffic in counterfeit medications.
Introduced by Sen. Patrick Leahy, D-Vt., S. 1886, the Counterfeit Drug Penalty Enhancement Act of 2011, would harshen laws against producing, buying or selling counterfeit drugs. The bill has received support from the chain retail pharmacy lobby.
"[The National Association of Chain Drug Stores] and the chain pharmacy industry applaud your leadership in taking steps to protect American consumers by advocating for stricter sentences for criminals in the counterfeit medicine business," a letter the organization sent to Sen. Leahy read. "Presently, the federal penalty for a counterfeiting crime is typically three years. We believe that stronger deterrents, as provided in your legislation, are more appropriate for these potentially deadly crimes involving counterfeit medicine."