Europe Likes Schering’s Bridion, But Not Takeda’s Rozerem
This article was originally published in The Pink Sheet Daily
Executive Summary
New opinion includes CHMP skepticism of insomnia drug.
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Recommendations for clearing Bridion and Doribax and for rejecting Rozerem along with a new indication for Revlimid were among a slew of new opinions published June 2 by Europe's Committee for Medicinal Products for Human Use. Schering Plough's Bridion (sugammadex), an injection designed to reverse effects of muscle relaxants used in general anesthesia, won a positive opinion for use in adults and children with the relaxants Exmeron (rocuronium) and Norcuron (vecuronium). On June 2, Kenilworth, N.J.-based Schering said its injection reversed muscle relaxation nine times faster than the standard of care in pooled Phase II and Phase III studies. Results were presented at the European Society of Anaesthesiology meeting, held from May 31 to June 3 in Copenhagen. Bridion, acquired via the buyout of Dutch firm Organon BioSciences last year, won backing from FDA's Advisory Committee on Anesthetics and Life Support in March, but the user fee date has been delayed to the third quarter of this year (1 (Also see "FDA Postpones PDUFA Date For Schering-Plough’s Bridion To Third Quarter" - Pink Sheet, 19 Mar, 2008.)). The CHMP also just recommended granting marketing clearance of Johnson & Johnson's carbapenem antibiotic Doribax (doripinem monohydrate) infusion for nosocomial pneumonia (including ventilator-assisted pneumonia), complicated intra-abdominal infections and complicated urinary tract infections. Non-inferiority trials comparing Doribax to the standard of care in all those indications bolstered the application. Doribax is on the table for evaluation by FDA's Anti-Infective Drugs Advisory Committee in July for nosocomial pneumonia, including ventilator-assisted pneumonia (2 (Also see "Promacta, Doribax Applications Get Advisory Committee Reviews" - Pink Sheet, 7 May, 2008.)). It was previously cleared in the U.S. for intra-abdominal and urinary tract infections. Among other negative opinions, CHMP gave the thumbs down to Takeda's Rozerem (ramelteon) for primary insomnia in adults. In its opinion statement, the committee said it was "concerned that the company had not demonstrated the effectiveness of ramelteon, which was measured considering only one aspect of insomnia, the time to fall asleep." The committee also critiqued a study supporting the marketing application, noting that the difference in effect on time to fall asleep between those taking the drug and those on placebo was "too small to be relevant." "When other aspects of sleep were considered, ramelteon did not have any effect," according to the opinion. "The committee was also concerned that the company had not demonstrated the long-term effectiveness of ramelteon." When it came to Celgene's immunomodulating agent Revlimid (lenalidomide), approved for treating multiple myeloma in Europe, the CHMP upheld a previous decision against a new indication in treating anemia caused by myelodysplastic syndromes. In the CHMP's view, the safety of Revlimid was "difficult to assess" for the new indication, due to design of the main study supporting the application 3 (Also see "Celgene Withdraws EU Filing For Revlimid After Second CHMP Refusal" - Pink Sheet, 2 Jun, 2008.)). "The study did not compare the medicine to any other treatment, it was difficult to determine if treatment increased the risk of progression to acute myeloid leukaemia," noted the committee. Extension of marketing authorization for Merck Sharp & Dohme's human papillomavirus vaccine Gardasil to include prevention of high-grade dysplastic lesions was recommended for marketing clearance. - Emily Hayes ([email protected]) |