FDA issues complete response letter to Bristol-Myers Squibb
PRINCETON, N.J. The Food and Drug Administration has declined to approve a biotech drug for organ transplant patients made by Bristol-Myers Squibb, Bristol said Saturday.
The FDA issued a complete response letter for Bristol’s September 2009 regulatory approval application for belatacept, designed to prevent rejection of transplanted kidneys. The agency issues a complete response letter when it has finished reviewing an application, but questions remain that preclude final approval. Specifically, the letter requested from Bristol three-year data from a late-stage clinical trial to further evaluate the drug’s long-term effect.
“Bristol-Myers Squibb is committed to belatacept as a potential new therapeutic option for kidney transplant patients,” Bristol SVP global development and medical affairs Brian Daniels said. “We will continue to work closely with the FDA to address their questions.”
FDA approves extended-release painkiller
CAMBRIDGE, Mass. The Food and Drug Administration has approved a regulatory approval application for a pain drug made by CombinatoRx, the drug maker announced Tuesday.
The FDA approved Exalgo (hydromorphone hydrochloride) extended-release tablets, for the management of moderate to severe pain in patients who need continuous pain relief for long periods of time.
Covidien will pay CombinatoRx a $40 million milestone payment for the approval and is eligible to receive tiered royalties on sales of the drug.
Surescripts: E-prescription use jumps 181%
ALEXANDRIA, Va. E-prescription adoption and use in the United States has skyrocketed over the past two years, according to a new report developed by an e-prescription network.
Surescripts, which announced the release of its 2009 national progress report on e-prescribing titled “Advancing Healthcare in America,” measures the growth of e-prescribing from 2007 through 2009 across a number of categories. Among the key findings: E-prescription use increased 181%, from 68 million in 2008 to 191 million e-prescriptions in 2009.
Additional findings included:
- Prescription Benefit Information: The number of electronic requests for prescription benefit information more than tripled, from 79 million in 2008 to 303 million in 2009
- Prescription History Information: The number of prescription histories delivered to prescribers grew more than five-fold, from 16 million in 2008 to 81 million in 2009
- Prescribers: The number of prescribers routing prescriptions electronically grew from 74,000 at the end of 2008 to 156,000 by the end of2009 — representing 25 percent of all office-based prescribers
- Pharmacies: At the end of 2009, approximately 85% of community pharmacies and six of the largest mail-order pharmacies in the United States were able to receive prescriptions electronically
Surescripts president and CEO Harry Totonis said the report emphasizes the benefits of e-prescribing.
“For e-prescription use to jump from 6% to 18% in one year indicates several things,” said Harry Totonis, president and CEO of Surescripts. “First, that the federal government’s leadership and incentive structures are working. Second, that the benefits of e-prescribing — including increased safety, lower costs and increased efficiency — are widely understood. And last, that the nation’s experience with e-prescribing — in building the network and the ecosystem to support it — provides a definitive road map for how to drive adoption of a broader electronic health record for all Americans.”