Big-name generics among new CHMP recommendations
pharmafile | April 27, 2015 | News story | Sales and Marketing | CHMP, EMA, European Medicines Agency, Lyrica, pregabalin
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended 11 new medicines for approval, among them several generic versions of blockbuster products.
Mylan and Sandoz, the generics arm of Novartis, have both had versions of Pfizer’s blockbuster Lyrica (pregabalin) approved for the treatment of epilepsy, anxiety disorder, and neuropathic pain.
However, the companies will be unable to market their products for neuropathic pain, as Pfizer still holds patents on that indication until July 2017. Pfizer has faced criticism for writing to doctors, pharmacists and CCGs in the UK warning them not to prescribe generic Lyrica for the condition.
Mylan also received a positive opinion for a generic version of Cymbalta (duloxetine), originally produced by Lilly. The loss of Cymbalta’s patents was cited as a key reason for a significant drop in sales for Lilly last year.
Sandoz also submitted its own version of this drug, but later withdrew it after the committee raised concerns about whether its studies had been carried out in accordance with Good Clinical Practice guidelines.
Meanwhile Pharmathen and Zentiva saw approvals for their versions of Bristol Myers-Squibb’s schizophrenia and bipolar disorder drug Abilify (aripiprazole). Abilify is BMS’ biggest-selling drug, but it is due to go off-patent in May.
There was also good news for BMS though, as its melanoma drug Opdivo (nivolumab) received a positive opinion from the CHMP.
Other new medicines recommended for approval were: orphan drug Hetlioz (tasimelteon) from Vanda Pharmaceuticals, for the treatment of non-24-hour sleep-wake disorder in totally blind adults; IDB Radiopharmacy’s LuMark (Lutetium (177Lu) chloride), for the radiolabelling of carrier molecules; and Daiichi Sankyo’s Lixiana (edoxaban) for the prevention of stroke and systemic embolism in atrial fibrillation, and the prevention and treatment of venous thromboembolism.
There was only one negative opinion in this round of CHMP decisions – Biovest‘s Lympreva (dasiprotimut-T) was rejected for the treatment of patients with follicular non-Hodgkin’s lymphoma as the committee considered the drug’s main study ‘inadequate’ and was unconvinced about the medicine’s effectiveness. It also had “concerns regarding some aspects of the manufacture and quality control of the medicine”.
George Underwood
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