FDA accepts regulatory filing for Prochieve
LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.
Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.
“We are pleased to achieve this important regulatory milestone and look forward to working with the FDA as they review the data package for the Prochieve new drug application,” Columbia president and CEO Frank Condella said.
Under a collaborative agreement between Watson and Columbia, Watson will make a $5 million milestone payment to Columbia.
Adding Byetta to diabetes regimen could cut heart failure risk
SAN DIEGO — Use of a drug for Type 2 diabetes made by Eli Lilly and Amylin Pharmaceuticals may lower patients’ risk of heart failure, according to a new study.
The study of more than 778,000 patients taking the injected drug Byetta (exenatide) found that adding the drug to a pre-existing diabetes regimen, especially if that regimen included insulin, was associated with reduced likelihood of heart failure. Results were presented Saturday at the 71st Scientific Sessions of the American Diabetes Association in San Diego.
The companies also are conducting another study for Bydureon, a long-acting formulation of Byetta. The study, called “EXSCEL,” began last year and will include about 9,500 patients with results expected as early as 2016. The study is designed to determine if Bydureon has favorable cardiovascular effects compared with traditional diabetes medications.
With law ban, marketing system for Rxs is safe… for now
WHAT IT MEANS AND WHY IT’S IMPORTANT — The law targeting data mining in Vermont, along with laws in New Hampshire and Maine, would have forced drug companies to significantly change the way they market drugs to physicians had the Supreme Court allowed them to stand in the case of Sorrell, Attorney General of Vermont, et al. vs. IMS Health Inc., et al.
(THE NEWS: Supreme Court strikes down Rx data mining law. For the full story, click here.)
When pharmacies fill prescriptions, they sell the data to such data mining companies as IMS Health, replacing patients’ identities with numbers but including their ages and genders, while retaining the prescribers’ names. The data mining companies then sell those data to drug companies, for which the data are critical to their marketing efforts because they allow the companies to determine such things as the demographics of various disease states, thus making it easier for them to tailor their sales pitches to physicians. IMS also provides a handy source of data for the charts illustrating sales and dispensing of drugs that frequently adorn the pages of Drug Store News.
But data mining has become controversial lately. In January, the Los Angeles Times ran an editorial attacking the practice, asserting that it violated patient privacy and expressing fears that it would allow drug companies to track individual patients. The controversy has led to efforts to enact laws that regulate it, requiring doctors’ consent before pharmacies can release prescribing data to data mining companies.
The Vermont law was well-intentioned in many ways: It was designed to encourage more prescribing of generic drugs by limiting the amount of data that branded drug companies can obtain, thus leveling the playing field. It’s well-known that generic drugs are cheaper for patients and can lower the cost of health care, but the Supreme Court decided that the law violated the free speech of drug companies and such data mining firms as IMS. As such, a critical component of the marketing system for prescription drugs appears safe, at least for now.