- Senate passes Drug Quality and Security Act
- FDA approves Plan B One-Step OTC switch
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- FDA approves liquid form of enalapril to treat BP in children, adults
- On the heels of Q3, Walgreens outlines shift in front-end strategy and pharmacy tailwinds looking forward
Supplier News — Fera Pharmaceuticals has recently launched two new topical ointments. The New York-based company has developed Ilotycin (erythromycin) and Garamycin (gentamicin) ophthalmic ointments, both for the treatment of bacterial infections of the eye. “Our goal is simple: to keep more quality healthcare choices alive for the people who need them,” company co-founder Frank DellaFera said.
Patients taking an investigational treatment for cardiovascular disease showed big improvements in cholesterol levels, according to late-stage clinical trial results. Merck announced results of its 18-month phase-3 trial of anacetrapib in 1,623 patients with coronary heart disease. The drug showed no difference in safety compared with placebo, and 16 patients experienced cardiovascular problems, including cardiovascular death, heart attack, unstable angina or stroke, compared with 21 taking placebo. Data were presented last month at the scientific sessions of the American Heart Association and were published online in the New England Journal of Medicine. Most importantly, after 24 weeks of treatment among patients who had previously taken a statin, the drug decreased “bad” LDL cholesterol by 40% while increasing “good” HDL cholesterol by 138%.
A decision by a Food and Drug Administration advisory committee could pave the way for the first new drug to treat lupus in decades. The FDA’s Arthritis Advisory Committee voted 13-to-2 to recommend approval for Benlysta (belimumab), a drug for systemic lupus erythematosus made by British drug maker GlaxoSmithKline and U.S.-based Human Genome Sciences, the two companies announced. Lupus is an inflammatory disorder that affects internal organs, joints and skin; in its severest forms, it can be fatal.
Due to the relative paucity of treatments available, the FDA granted priority review to the drug in August. If approved, Benlysta could be the first new treatment for lupus in more than 50 years. The FDA advisory committee’s decisions don’t guarantee approval, but are taken into account by the FDA.
An investigative treatment for allergies made by Teva Pharmaceutical Industries appears to work, according to results of a late-stage clinical trial. Teva said phase-3 data from a study of Qnaze HFA (beclomethasone dipropionate), designed to be inhaled through the nose, was effective in treating patients with seasonal allergic rhinitis, while safety results were similar to those for placebo. Data from the study were presented at the annual meeting of the American College of Allergy, Asthma and Immunology in Phoenix.
“The results of this pivotal clinical trial suggest that Qnaze HFA may be efficacious and safe for individuals seeking relief from the nasal symptoms associated with their seasonal allergies,” study lead investigator Jay van Bavel said.
Generic injectable drug maker Hospira announced the launch of gemcitabine hydrochloride — a generic version of Eli Lilly’s chemotherapy drug, Gemzar, in 2-g vials. Gemzar had sales of nearly $750 million in 2009, according to Hospira.
The FDA approved the first and only once-a-day metformin extended-release plus dipeptidyl peptidase-4 inhibitor combination tablet for the treatment of Type 2 diabetes. Bristol-Myers Squibb and AstraZeneca’s Kombiglyze XR offers strong glycemic control across HbA1c levels, fasting plasma glucose and post-prandial glucose. Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate, the drug companies said.
The FDA approved once-a-day Kombiglyze XR based on two phase-3 clinical trials and bioequivalence studies. The two clinical studies evaluated the efficacy and safety of saxagliptin and metformin IR as separate tablets compared with placebo added to metformin IR. Bioequivalence was demonstrated in healthy adults between Kombiglyze XR and saxagliptin plus metformin XR as separate tablets.
“Nearly half of adult patients remain uncontrolled on their current treatment regimen and may thus require additional medications,” said Elliott Sigal, EVP, chief scientific officer and president of research and development at Bristol-Myers Squibb. “With our heritage of bringing metformin — the most widely prescribed oral anti-diabetic medication — and more recently saxagliptin to patients in the United States, we are committed to making Kombiglyze XR the newest building block in our long-term commitment to helping adult patients with Type 2 diabetes.”