FDA Pipeline Preview, February 2012 (Bristol-Myers Squibb, AstraZeneca, Columbia Laboratories, Watson Pharmaceuticals, Achillion, Catalyst Pharmaceutical Partners, AlloCure, Neurocrine Biosciences, AiCuris, CanBas, Pinnacle Biologics, Ikaria)
- Dapagliflozin (Bristol-Myers Squibb, AstraZeneca) investigational compound, an inhibitor of SGLT2, for the treatment of type 2 diabetes in adults.The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials. Bristol-Myers Squibb and AstraZeneca said it will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.
Not recommended forapproval
- Progesterone vaginal gel 8% (Columbia Laboratories, Watson Pharmaceuticals) for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy.
- ACH-1625 (Achillion) once-daily protease inhibitor for the treatment of chronic hepatitis C virus.
- CPP-115 (Catalyst Pharmaceutical Partners), a novel GABA aminotransferase inhibitor for the treatment of cocaine dependency.
- AC607 (AlloCure) for treatment of acute kidney injury.
- NBI-98854 (Neurocrine Biosciences) VMAT2 inhibitor for the treatment of neuroleptic-induced tardive dyskinesia.
Orphan drug designations
n Inhaled nitric oxide (Ikaria) with the INOpulse DS drug-delivery system as a combination product for the treatment of pulmonary arterial hypertension.
- HT-100 (Halo Therapeutics) for treatment of Duchenne muscular dystrophy.
- AIC246 (Letermovir, AiCuris), a novel inhibitor against the human cytomegalovirus HCMV for the prevention of HCMV viremia and disease in at-risk populations.
- CBP501 (CanBas) for use in combination with cisplatin and pemetrexed for treatment of patients with malignant mesothelioma.
- Porfimer sodium (Photofrin, Pinnacle Biologics) as adjuvant therapy to surgery in the treatment of malignant pleural mesothelioma.
MORE ARTICLES IN THIS ISSUE
Drug Watch: Cardiovascular agents
Immunization update: A 2011 retrospective on product changes and new recommendations
Vaccines are one of the greatest achievements of biomedical science and public health. Proper vaccination plays a critical role in the reduction of vaccine-preventable disease and related morbidity and mortality.
Hospital-acquired C. difficile lengthens hospital stay, retrospective study shows
Hospital-acquired Clostridium difficile significantly prolongs the duration of a patient's stay in the hospital by at least 6 days, according to the findings of a study published online December 5, for the Canadian Medical Association Journal.
FDA adverse drug events app for public health crises could expand to more general adverse event reporting
Prompted by the 2009 H1N1 influenza outbreak, FDA has announced plans to create a mobile app that will help it gather information and send out alerts about adverse reactions to experimental medications prescribed during public health crises.
FDA Actions in Brief February 2012 (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)