The European Medines Agency has issued its latest opinions which include good news for Schering-Plough’s new anaesthesia drug sugammadex but a negative verdict for Takeda’s insomnia treatment ramelteon and another rejection for Celgene’s lenalidomide as an anaemia treatment.

First up, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, thus recommending marketing authorisation, for Bridion (sugammadex), S-P’s treatment (inherited from Organon) for the reversal of neuromuscular block induced by rocuronium or vecuronium. The company has high hopes for sugammadex and believes it will transform the practice of anaesthesia through improved management of muscle relaxation.

The CHMP has also recommended expanded approval of Johnson & Johnson’s Doribax (doripenem) for the treatment of adult patients with nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections.

Faring much worse was Takeda’s primary insomnia drug for adults, ramelteon. The committee said it was concerned that the company had not demonstrated the long-term effectiveness of the drug, which was approved for sale as Rozerem in the USA in 2005, so a negative opinion was given.

Celgene pulls lenalidomide application in Europe
More bad news came out of the EMEA for Celgene after the agency again turned down lenalidomide, following the re-examination of a negative opinion adopted in January, as a treatment of anaemia due to myelodysplastic syndromes (MDS). The CHMP said it had concerns over the way the main study was carried out, which meant that the safety of the drug was difficult to assess.

In particular, “because the study did not compare the medicine to any other treatment”, it was difficult to determine if it increased the risk of progression to acute myeloid leukaemia, the CHMP said. In addition, an inspection of one of the sites where the study was carried out “showed some concerns with the way the results were recorded, and this can further affect the reliability of the main study”.

Celgene responded by saying it had withdrawn its European marketing application for the product, sold in the USA, Canada and Argentina as Revlimid but it is continuing its clinical development programme of lenalidomide “with the intention to seek marketing approval in MDS”.

The drug is already approved in the major markets for the treatment of multiple myeloma in combination with dexamethasone in patients who have received at least one prior therapy. Revlimid has attracted a lot of attention at the American Society of Clinical Oncology meeting in Chicago after Celgene presented mid-stage data which showed that out of 83 patients who had received prior treatment for non-Hodgkin's lymphoma, 23% achieved a partial response, while 6% showed a more substantial complete response.