Eli Lilly, Amylin announce clinical trial results of exenatide
INDIANAPOLIS A drug under review by the Food and Drug Administration as a treatment for diabetes provided better glucose control than the competition, the drug’s developers said Monday.
Eli Lilly & Co., Amylin Pharmaceuticals and Alkermes announced results of a phase 3 clinical trial comparing a once-weekly formulation of exenatide, the active ingredient in the drug Byetta, to Sanofi-Aventis’ Lantus (insulin glargine [rDNA origin]). The trial found that patients taking exenatide experienced reductions in average blood sugar levels of 1.5%, compared with 1.3% among those taking Lantus. Exenatide also resulted in an average weight loss of 5.8 lbs. after 26 weeks, compared with 3.1 lbs. among Lantus patients.
“Exenatide once-weekly outperformed Lantus in this superiority study by meeting its primary endpoint,” Amylin Pharmaceuticals SVP research and development Orville Kolterman said in a statement.
The study enrolled 467 patients with Type 2 diabetes, with more than 90% of patients completing it.
Human Genome Sciences, GSK announce trial results for systemic lupus treatment
ROCKVILLE, Md. An investigational biotech drug for treating systemic lupus has done well in late-stage clinical trials so far, the two companies developing the drug announced Monday.
Human Genome Sciences and GlaxoSmithKline announced that the drug Benlysta (belimumab) met its primary efficacy goal in BLISS-52, the first of two phase 3 trials comparing it to standard methods of care and placebo in patients with systemic lupus erythematosus, also known as SLE. The companies said Benlysta was the first lupus drug to reach this advanced a stage in clinical development.
“The BLISS-52 results demonstrate that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus,” Human Genome Sciences president and CEO H. Thomas Watkins said in a statement. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments.”
The two companies entered an agreement to develop and commercialize Benlysta in August 2006.
FDA approves two additional strengths of generic schizophrenia drug
PITTSBURGH The Food and Drug Administration has approved two additional strengths of a generic version of a common schizophrenia drug.
Mylan announced Monday the approval of its haloperidol tablets in the 10 mg and 20 mg strengths. The company already markets the drug in strengths of 0.5 mg to 5 mg.
Haloperidol is used to control the symptoms of schizophrenia and Tourette syndrome and is a generic version of Johnson & Johnson’s Haldol, though J&J no longer manufactures Haldol in the tablet form. Haloperidol had sales of $21 million for the 12 months ending in March, according to IMS Health data.