The Food and Drug Administration has approved a new use for Salix Pharmaceuticals’ Xifaxan (rifaximin), the FDA announced. The drug’s new use is for treating hepatic encephalopathy, a deterioration in brain functioning in patients with liver disease that results from the liver’s no longer being able to clear toxins from the body. The drug already had approval for treating traveler’s diarrhea.
The FDA has given tentative approval to Teva Pharmaceutical Industries’ generic version of GlaxoSmithKline’s Argatroban (argatroban), Teva announced. The authorization was given to the injected drug argatroban, a generic version of GSK’s drug for treating heparin-induced thrombocytopenia. The branded version of the drug has annual sales of around $137 million, according to IMS Health.
The FDA has given orphan drug designation to rh-GAD65, a vaccine for Type 1 diabetes made by Diamyd Medical, the Swedish drug maker announced. The drug is in late-stage development for Type 1 diabetes with residual beta cell function. The FDA grants orphan drug designation to therapies for diseases that affect fewer than 200,000 Americans.
The drug is undergoing a phase 3 clinical trial testing whether it can slow the destruction of insulin-producing beta cells, thus preserving the body’s ability to control blood sugar levels. The trial is still enrolling patients.
Innovation is the way to improve quality and access to health care while controlling costs, the leader of drug maker Eli Lilly said in an address in Germany on March 25. Lilly chairman, president and CEO John Lechleiter appeared at the American Chamber of Commerce in Germany, saying that innovative medicines can further improve people’s health and replace more expensive treatments, while also providing economic benefits by generating research jobs. He also said societies should shift their thinking with regard to healthcare reform, “from an emphasis on cost to an understanding of value.”
“New medicines to provide better treatment for the pandemic of diabetes, to alleviate the growing human and economic toll of Alzheimer’s disease or to address countless other unmet medical needs around the world could have dramatic positive impacts not only on the quality [of] human life, but also on the capacity of our healthcare systems and the costs they incur,” Lechleiter said.
Less than a month after winning approval for treating early stages of Parkinson’s disease, a Boehringer Ingelheim drug has won additional approval for treating the disease from the FDA, Boehringer Ingelheim announced. The FDA approved the once-daily pill Mirapex ER (pramipexole dihydrochloride) for signs and symptoms of advanced idiopathic Parkinson’s disease.
Lupin Pharmaceuticals has received tentative approval for eszopiclone tablets in 1-mg, 2-mg and 3-mg strengths. The tablets are the generic equivalent of Sepracor’s Lunesta, a popular insomnia treatment.
Lunesta garnered annual sales of approximately $761 million for the 12 months ended December 2009, based on IMS Health sales data.
Schnucks’ O’Brien to serve on Department of Agriculture advisory committee
ST. LOUIS An executive from Schnuck Markets will serve on an advisory committee of the Department of Agriculture, Schnucks said this week.
Agriculture secretary Tom Vilsack announced that Schnucks VP produce and floral Mike O’Brien would be one of 25 people appointed to a two-year term on the USDA’s Fruit and Vegetable Industry Advisory Committee. O’Brien is also vice chairman of the Produce Marketing Association.
“I am honred to represent Schnuck Markets and the retail produce industry as a member of this committee,” O’Brien said. “I am looking forward to the opportunity to contribute and to make a difference for families across the nation.”
The committee, originally chartered in 2001, advises the secretary of agriculture on industry issues related to fruits and vegetables.
Gilead commences phase 3 trial for single-tablet HIV treatment
FOSTER CITY, Calif. Gilead Sciences has started a late-stage clinical trial of an investigational 4-in-1 treatment for HIV, the drug maker said.
Gilead announced the initiation of a phase 3 trial of its “Quad” HIV drug, a single-tablet treatment that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The study will compare the Quad regimen with the standard of care among adults with HIV-1 who have not taken antiretroviral treatments. The company is also investigating cobicistat as a standalone boosting agent for antiretroviral drugs.
“We are pleased to announce that the Quad phase 3 clinical program is underway,” Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. “Efficacy and safety results from the phase 2 study suggest that the Quad may represent an important new option for patients with HIV.”