Amylin seeks FDA approval for metreleptin
SAN DIEGO — Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.
Amylin announced the submission of an application to the Food and Drug Administration for metreleptin in patients with rare forms of lipodystrophy, a life-threatening disorder estimated to affect only a few thousand people around the world. The disease results from the body’s inability to create the hormone leptin, resulting in fat buildup in the blood and organs like the liver and muscles, causing such life-threatening complications as insulin-resistant diabetes, high triglycerides in the blood — also known as hypertriglyceridemia — acute pancreatitis and others.
"Completion of this submission is an important milestone for Amylin and for patients with rare forms of lipodystrophy who currently have limited and often insufficient treatment options for this under-recognized and life-threatening disease," Amylin president and CEO Daniel Bradbury said. "Metreleptin is an integral component of our ongoing commitment to improve the lives of patients with metabolic diseases, from the rarest to the most prevalent."
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Watson seeks approval for generic Lumigan, Latisse
PARSIPPANY, N.J. — Watson is challenging the patent protection on two eye drugs made by Allergan, the generic drug maker said Tuesday.
Watson announced that it had filed with the Food and Drug Administration for generic versions of Allergan’s Lumigan and Latisse (bimatoprost) ophthalmic solution. The products contain the same active ingredient in the 0.01% and 0.03% strengths, respectively, and are used to reduce pressure within the eye in patients with open-angle glaucoma or ocular hypertension.
In response to Watson’s filings, Allergan filed suit against the company in the U.S. District Court for the Eastern District of Texas on March 23 to prevent Watson from launching a generic version of Lumigan. In addition, Allergan and Duke University sued Watson in the U.S. District Court for the Middle District of North Carolina on Saturday to prevent the launch of Latisse.
The lawsuits put a stay of final FDA approval on Watson’s products for 30 months or until the companies reach a settlement.
Lumigan and Latisse had respective sales of $409 million and $80 million during the 12-month period ended in January, according to IMS Health.
I think this would be great news for the Cost of Latisse. Currently the price point is down to $79 from latisse.bz Further price reductions would allow the benefits to reach the greater population.
Walgreens immunization studies: Pharmacy instrumental in helping states combat disease
DEERFIELD, Ill. — Walgreens on Tuesday released case studies presented last week before the Centers for Disease Control and Prevention’s 2012 National Immunization Conference on how retail pharmacy can expand access to immunizations and help support disease-prevention initiatives.
The studies demonstrated the impact of three Walgreens initiatives aimed at increasing immunization rates: off-clinic hour vaccine administration, a pharmacist-led meningitis vaccination program and expansion of access to immunization services in underserved areas.
The first study examined patient populations receiving vaccinations during off-clinic hours (defined as times when traditional physician offices and clinics are closed) between August 2010 and July 2011 across various demographics. As many as 25.4% of seniors visited Walgreens during off-clinic hours for vaccinations as did more than one-third (37.1%) of working-age adults.
A pharmacist-led meningitis vaccination program in Texas drove the number of vaccinations provided by Walgreens pharmacists dramatically year-over-year from 41 in January 2011 to 11,229 in January 2012, and the proportion of meningitis vaccinations provided in medically underserved areas increased by 27.4% from January 2011 to January 2012. The program was implemented in support of a Texas state mandate requiring all college students younger than 30 years of age to be immunized for meningitis before the January 2012 semester and demonstrates that community pharmacies can support state government initiatives and improve public health.
The third study examined the impact of food oasis pharmacies on influenza vaccination rates in Chicago underserved areas and food deserts. This study investigated the rate of influenza vaccinations administered to patients during the 2010-2011 flu season visiting Walgreens pharmacies in urban neighborhoods of Chicago located in or adjacent to food deserts (areas without sufficient access to healthy food) that were converted to food oasis pharmacies (offering a larger assortment of healthy meal components including fresh fruits, vegetables, whole grains and prepared items), compared with a matched sample of patients visiting traditional Walgreens pharmacies.
The study found that in pharmacies that converted to food oases, the rate of influenza vaccinations increased by 75% (from 15.9 to 28 per 1,000 pharmacy patients). This rate was significantly higher than the 50% increase (15.5 to 23.2 per 1,000 pharmacy patients) observed in traditional pharmacies. The study implied that the introduction of food oasis pharmacies, as healthy destinations near food deserts, have further contributed to the observed increase in the rate of influenza vaccinations, Walgreens said.
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