On a busy day for the regulator, the European Medicines Agency has recommended that marketing authorisation be suspended for Merck KGaA/Genentech’s psoriasis drug Raptiva over possible links between the drug and a rare but deadly brain infection.
The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said the benefits of Raptiva (efalizumab) no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The CHMP noted three confirmed cases of PML in patients who had taken Raptiva for more than three years, two of resulted in the patient’s death, and the agency has received an additional report of a suspected case of PML, “which could not be confirmed”.
Nevertheless, following a review, the CHMP has concluded that “Raptiva’s benefits are modest”. In addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barre and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections,” the EMEA noted. It added that “there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks”.
The EMEA’s call for suspension came as its counterpart in the USA, the Food and Drug Administration, issued a public health advisory about the three confirmed reports of PML and the possible fourth case. The FDA stated that it will “take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits”.
Merck, which markets Raptiva in Europe, said it would work with health authorities across the continent “to undertake all necessary measures to comply with the EMEA recommendations.” Earlier this week, the Darmstadt-based group noted that it had written off 195 million euros due to “sharply lower sales expectations” for the drug.
Staying with the EMEA, the agency has issued the latest list of positive opinions from the CHMP. The drugs recommended for approval include Wyeth’s Conbriza (bazedoxifene) for postmenopausal osteoporosis, Bial’s anti-epileptic Zebinix (eslicarbazepine; see story on today’s elert) and Fresenius’ Removab (catumaxomab) for the removal of cancerous fluid from the abdomen.
The CHMP is also recommending approval for Nycomed’s over-the-counter versions of its own heartburn drug Pantozol (pantoprazole) and Teva’s generic version of Novartis’ anti-dementia drug Exelon (rivastigmine). However, it adopted a negative opinion for Biferonex (interferon-beta-1a), from Switzerland’s BioPartners, for multiple sclerosis. BioPartners is appealing the decsion, claiming that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market”.
