CHMP roundup
pharmafile | May 24, 2011 | News story | Sales and Marketing | CHMP, EMA, Fampyra, Vibativ, Victrelis, Xgeva, Yervoy
The latest products to be recommended for European approval include MSD’s Victrelis, Astellas Pharma Europe’s Vibativ, Amgen Europe’s Xgeva and BMS’ Yervoy.
The Committee for Medicinal Products for Human Use (CHMP) gave Merck Sharp & Dohme’s hepatitis C drug Victrelis the nod after an accelerated assessment, and marketing authorisation from the European Commission is likely in the next few months.
Victrelis (boceprevir) is to be used to treat chronic hepatitis-C genotype-1 infection in combination with Roche’s Pegasys (peginterferon alpha) and ribavirin, in adults with liver disease who are previously untreated or for whom previous therapy has failed.
It is a double whammy for Merck: earlier this month Victrelis became the first oral hepatitis C treatment to be approved by the FDA.
The drug has been seized upon by regulators as it may answer an unmet medical need. It works by directly inhibiting the replication of the hepatitis-C virus in hepatitis-C-virus-infected host cells.
Merck also entered a co-promotion agreement with Roche that will see both companies including the other’s hepatitis C drugs in their sales presentations in the US.
Meanwhile the CHMP has also given the nod to Astellas Pharma Europe’s Vibativ (telavancin), for nosocomial pneumonia caused by so-called superbug methicillin-resistant Staphylococcus aureus (MRSA).
It is the first antibacterial medicine to receive a positive opinion in two years, “albeit in a restricted indication, addressing an increased need for new antibiotics,” the CHMP says.
Other drugs on the regulator’s list include Amgen Europe’s Xgeva (denosumab), for the prevention of skeletal-related events in adults with bone metastases from solid tumours.
And Bristol-Myers Squibb’s skin cancer treatment Yervoy (ipilimumab), which received FDA approval earlier this year for advanced, inoperable or metastatic melanoma – the deadliest and most aggressive form of the disease – now also has CHMP support.
It is potentially a massive moneyspinner for BMS, with analysts predicting sales of $820 million to $1.7 billion by 2015.
Finally, the CHMP recommended granting a conditional marketing authorisation for Biogen Idec’s Fampyra (fampridine), while it waits for further evidence.
This is a victory for the company, since the regulator had initially given a negative opinion of the drug, which is intended to improve walking of adults suffering from multiple sclerosis with walking disability.
Biogen will be expected to provide a long-term efficacy and safety study on a “clinically meaningful” endpoint in terms of walking ability.
The European Medicines Agency will review new information within one year and update the product information if necessary.
• The CHMP also recommended GlaxoSmithKline’s first-in-class lupus drug Benlysta (belimumab).
The EU recommendation is for Benlysta as an add-on treatment for adults with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity despite taking standard therapy.
Adam Hill
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