The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have brought a couple of pieces of good news for Johnson & Johnson, while a number of generic versions of the diabetes drug Actos have been backed.
First up, the CHMP has recommended approval of J&J’s Zytiga (abiraterone acetate) in combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in men whose disease has progressed on or after docetaxel-based chemotherapy. The agency noted that it assessed the drug under an accelerated timetable, because it considered “that the poor prognosis of the target patient population represents a high unmet medical need while the novel mechanism of action of abiraterone has the potential to offer an alternative therapeutic option”.
Zytiga was approved by the US Food and Drug Administration last month and analysts believe that it will be a blockbuster. In trials, the treatment has been shown to increase survival for an extra four months.
The CHMP has also backed J&J’s Incivo (telaprevir) for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease, again under an accelerated timetable. Telaprevir belongs to a new class of medicines that can directly inhibit viral replication in infected host cells “which can lead to the eradication of the virus, and thus effectively to a cure of chronic hepatitis C”.
Some 70% of hepatitis C virus infections in the Western world are genotype 1, so approving the drug, which got the green light from the FDA in May, “would be an important public health gain”, the committee stated. Incivo was co-developed by J&J, Vertex Pharmaceuticals (which will sell the drug in the USA as Incivek) and Japan’s Mitsubishi Tanabe Pharma Corp.
Thumbs-up for Pfizer orphan drug
The CHMP has also backed Pfizer’s Vyndaqel (tafamidis) for the treatment of transthyretin amyloidosis in adult patients with symptomatic polyneuropathy. This is the the first oral drug to be recommended for this progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option currently available.
The CHMP has recommended granting a marketing authorisation under exceptional circumstances because, due to the rarity of the disease, Pfizer has not yet been able to provide “comprehensive evidence on the efficacy and safety of this medicine”.
There were also positive opinions for Dexdor (dexmedetomidine) from Finland’s Orion, for sedation of adult intensive care unit tients and Plenadren (hydrocortisone), an orphan medicine from DuoCort Pharma, intended for the treatment of adrenal insufficiency.
The Committee adopted positive opinions on generics of UCB’s antiepilepsy treatment Keppra (levetiracetam) from Accord Healthcare, Actavis and Pharmathen. It has also backed copycat versions of Actos (pioglitazone) from Accord, Teva’s Ratiopharm subsidiary and Krka and copies of two Boehringer Ingelheim drugs – Mirapexin/Sifrol (pramipexole) for Parkinson’s disease and restless legs syndrome and the antihypertensive Micardis (telmisartan) – made by Accord and Teva respectively.
The CHMP has also backed extending the approved indications for Novartis’ Afinitor (everolimus), Pfizer’s Enbrel (etanercept) and Roche’s Tarceva (erlotinib). The committee added that it has been informed by Sanofi’s recently-acquired Genzyme Corp unit that shortages of its thyroid drug Thyrogen (thyrotropin alfa) will continue to be restricted until 2012, due to a manufacturing issue – the problem was supposed to have been resolved by this month.
