FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep
SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.
The agency announced Wednesday the approval of Intermezzo (zolpidem tartrate) sublingual tablets, made by Port Richmond, Calif.-based Transcept Pharmaceuticals. The drug contains the same active ingredient as Sanofi’s Ambien but at a lower dose. Zolpidem already has lost patent protection, allowing other companies not only to make generic versions of it, but also to develop "branded generics" that are novel formulations of it, as Transcept has done.
"For people whose insomnia causes them to wake in the middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," FDA Center for Drug Evaluation and Research deputy center director Robert Temple said. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."
Pfizer to sell Lipitor directly by mail
NEW YORK — Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.
The Wall Street Journal reported that Pfizer would partner with health plans to sell Lipitor (atorvastatin) directly to consumers through the mail when the drug’s patent expires at the end of the month, opening the drug to generic competition.
Lipitor has sales of more than $7 billion a year in the United States, according to IMS Health, but Pfizer’s sales are likely to take a dip when India’s Ranbaxy Labs launches its long-awaited generic version.
Shire seeks approval to make Gaucher disease drug at new plant
LEXINGTON, Mass. — British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.
The company said Tuesday that it had filed with the Food and Drug Administration and the European Medicines Agency for approval to produce the Gaucher disease drug Vpriv (velaglucerase alfa) at its Lexington, Mass., plant. The company expects to win approval to make the drug there early next year.
After gaining approval, the company said it hopes to ramp up manufacturing of the Fabry disease drug Replagal (agalsidase alfa) at its plant in Alewife, Mass., near Boston, where it currently makes Replagal and Vpriv. Replagal is approved in 46 countries, but not the United States. Currently, 1,200 people receive Vpriv and 2,800 receive Replagal worldwide, according to the company.
"Shire remains committed to meeting the unique needs of patients living with rare diseases," Shire Human Genetic Therapies SVP technical operations Bill Ciambrone said. "Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for Vpriv less than two years after launch. Once approved, this new facility will give us greater flexibility to meet the global demand for Vpriv, as well as some of our other products for rare diseases."