The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted includes rejection for an expanded approval of Eli Lilly’s antidepressant blockbuster Cymbalta and good news for Sepracor’s insomnia drug Lunivia.
Perhaps most surprising was the CHMP’s decision to adopt a negative opinion on Lilly and partner Boehringer Ingelheim’s application for Cymbalta (duloxetine) for the treatment of fibromyalgia. The committee concluded that the effectiveness of the drug had not been sufficiently shown and the benefits did not outweigh its risks.
James Russell, global medical director for Cymbalta at Lilly, said his firm and Boehringer “are naturally disappointed by the CHMP’s opinion” but said “remain confident in the duloxetine data”. Currently, there are no medications approved in the European Union to treat the disease, though Cymbalta was granted marketing authorisation for fibromyalgia by the US Food and Drug Administration in June.
There was better news for Sepracor which received a positive opinion for Lunivia (eszopiclone) as a treatment for insomnia in the EU. The committee said that the labelling “provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short-term.”
However, Sepracor chief executive Adrian Adams said the firm is considering “requesting a re-examination of the opinion relating to the exclusion of a new active substance designation that we feel would enable more favourable commercialisation of the product”. In 2007, the company entered into an agreement with GlaxoSmithKline for the commercialisation of eszopiclone worldwide, excluding North America, where the drug is marketed as Lunesta, and Japan.
Positive opinions for Vidaza, Erbitux
There was also good news for Celgene which announced that its cancer drug Vidaza (azacitidine) has received a positive opinion from the CHMP for the treatment of myelodysplastic syndromes and acute myeloid leukaemia. The committee also backed an extension of the label for Merck KGaA’s Erbitux (cetuximab) as an initial treatment of recurrent or metastatic squamous-cell cancer of the head and neck in combination with platinum-based chemotherapy.
The drug is already cleared for use in combination with radiotherapy for locally advanced head and neck tumours and Merck said it expected the new indication to raise the annual number of the drug’s target patients by about 100,000 in Europe.
Astellas pulls telavancin file in Europe
Staying with the EMEA and Japan’s Astellas Pharma has withdrawn a marketing authorisation application to the agency for telavancin, a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and soft tissue infections. The drug has received an unfavourable review from the CHMP but Astellas but hopes to refile telavancin with additional data from its hospital-acquired pneumonia Phase III studies.
