Prasugrel given priority review by FDA
WASHINGTON A new drug, prasugrel, manufactured by Eli Lilly and Daiichi Sankyo, has been granted a priority review by the Food and Drug Administration.
The drug is intended for the prevention of blood clots, and if approved, will be competing against Plavix, the blockbuster drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis. A study conducted in November has already shown that prasugrel was 19 percent more effect than Plavix, but resulted in a higher amount of serious bleeding.
A priority view, according to published reports, means that the FDA will decide within six months whether or not to approve the drug. An approval for a drug usually takes about 10 to 12 months.
The application for prasugrel was filed on December 26, and since the news of its priority view its shares rose up nearly 3 percent. If approved, Lilly plans its drug to be brand named Effient.
Eli Lilly introduces its third new insulin pen in the past year
INDIANAPOLIS Eli Lilly today launched its new insulin pen, KwikPen, which is prefilled with the Humalog brand of insulins. This is the third new insulin pen launched by the company in the last 12 months, following the launches of HumaPen MEMOIR, a digital insulin pen and HumaPen LUXURA, a reusable pen for people who need insulin dosing in smaller increments.
KwikPen is now available by prescription in pharmacies prefilled with the Humalog brand of insulins, including Humalog, Humalog Mix75/25 and Humalog Mix50/50. Patients using the original Humalog and Humalog Mixtures prefilled pen do not need to convert at this time.
“KwikPen, prefilled with Humalog and Humalog Mixtures, provides people with diabetes an exciting new option for accurate insulin dosing with the convenience of an easy-to-use prefilled pen,” said Matt Beebe, Humalog brand leader, Lilly USA.
Pfizer to acquire Encysive, will gain rights to Thelin
NEW YORK Pfizer has announced that it intends on buying Encysive Pharmaceuticals for about $195 million, according to the Associated Press.
As part of the deal, Pfizer would gain the rights to Encysive’s drug Thelin, which is approved in some European countries for the treatment of high blood pressure in the pulmonary artery. The drug is still awaiting approval in the U.S. Pfizer would also gain access to the rest of Encysive’s portfolio of drugs.
Pfizer already markets Revatio for high blood pressure in the pulmonary artery and Thelin would only strengthen the market for the company. Pfizer plans on conducting a late-stage trial of Thelin in the U.S. in hopes of obtaining final approval from the Food and Drug Administration.
Analysts project the drug could make about $100 million annually by 2012.