EMEA Issues Negative Opinion For Novartis’ Anti-Infective Mycograb
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm also receives positive opinions from EU authorities on hypertension combo Exforge and macular degeneration treatment Lucentis.
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Novartis will submit additional information to the European Medicines Agency's Committee for Medicinal Products for Human Use in hopes of gaining approval for its anti-infective Mycograb (efungumab). During its Nov. 13-16 meeting, the committee adopted a negative opinion for Mycograb in the treatment of adult patients with invasive candidiasis. "The CHMP was concerned about some aspects of the quality of the medicine," the EMEA said in a Question & Answer document. "It also had concerns about the safety of Mycograb. The medicine is associated with 'cytokine release syndrome,' a condition that can cause nausea, vomiting, pain and also hypertension, but the reason is not clear." Novartis said the CHMP opinion does not relate to efficacy, and the firm is "committed to working with the CHMP to determine the appropriate next steps." Novartis acquired Mycograb when it purchased Manchester, England-based NeuTec Pharma earlier this year ("1 (Also see "Novartis Could Add To Its Hospital-Acquired Infection Portfolio With Acquisition" - Pink Sheet, 7 Jun, 2006.)). NeuTec has previously said it planned to submit a Mycograb BLA to FDA in 2009. Last month, FDA approved Schering-Plough's Noxafil (posaconazole) oral suspension for the treatment of oropharyngeal candidiasis ("2 (Also see "Noxafil Gains Additional Oropharyngeal Candidiasis Indication" - Pink Sheet, 24 Oct, 2006.)). Pfizer's Eraxis (anidulafungin) was approved in February for several Candida-related claims (3 (Also see "Pfizer To Spring Forward With Eraxis Launch" - Pink Sheet, 21 Feb, 2006.)). CHMP also provided Novartis with some good news, recommending approval for the firm's hypertension combo treatment Exforge (amlodipine/valsartan) and its neovascular (wet) age-related macular degeneration treatment Lucentis (ranibizumab). Exforge has an estimated FDA user fee date of late December based on a standard 10-month review (4 (Also see "Novartis’ Exforge Has Late December User Fee Date" - Pink Sheet, 27 Apr, 2006.)). In addition, CHMP recommended approval for Eisai's seizure treatment Inovelon (rufinamide) and gave positive opinions for indication extensions for UCB's Keppra (levetiracetam) to "include the treatment of primary generalized tonic-clonic seizures as adjunctive therapy in adults and adolescents from 12 years of age with idiopathic generalized epilepsy." CHMP also recommended an indication extension for Schwarz BioSciences' Neupro (rotigotine transdermal system) to "include the treatment of the signs and symptoms of advanced-stage idiopathic Parkinson's disease in combination with levodopa." In the U.S., Neupro has been "approvable" since the first quarter (5 (Also see "Schwarz To Patch Up Neupro NDA Within Six Months Following “Approvable” Letter" - Pink Sheet, 1 Mar, 2006.)). In July, CHMP adopted a negative opinion regarding marketing authorization of Novartis' investigational antidepressant agomelatine (6 (Also see "Novartis’ Newly Licensed Antidepressant Hits Snag In EU Under Separate Sponsor" - Pink Sheet, 28 Jul, 2006.)). -Daniel Fowler ([email protected]) |