Recent approvals of drugs that make a difference !
By Kim Bill on May 23, 2011 | In Drug Development
And by both the FDA and EMEA!
1)Benlysta(belimumab)(GSK / Human Genome Sciences)systemic lupus drug. 1st new drug for the disease in 50 years. Peak sales in 2015 est. $3B
2)Yervoy (ipilimumab) (BMS) - treatment of patients with previously-treated unresectable or metastatic melanoma. The 1st new melanoma treatment approved in Europe in a decade. Sales est $1.5B
3) Victrelis (boceprevir)(Merck)- for the treatment of chronic hepatitis-C genotype-1 infection, in combination with SOC, in adult patients with compensated liver disease who are previously untreated or for whom therapy has failed. The CHMP's positive opinion comes just 120 days after a review began on the first-in-class protease inhibitor, reflecting unmet medical need. est sales $1B
Other good news:
Acorda Therapeutics-the CHMP reversed its earlier recommendation against Fampyra, a drug designed to improve walking ability in multiple sclerosis patients. The panel recommended conditional approval of the drug, which will be marketed by Biogen Idec in Europe. Ampyra was approved in the US in 2010. Biogen will have to carry out a "long-term efficacy and safety study to investigate a broader primary endpoint that is clinically meaningful in terms of walking ability", the CHMP noted, and "evaluate the early identification of responders in order to guide further treatment". see post Oct 2010 Ampyra
Amgen's Xgeva (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumours. The drug is already approved under the brand-name Prolia, for osteoporosis, and Amgen has also just released Phase III data which showed that denosumab significantly increased bone metastasis-free survival for more than four months in men with advanced prostate cancer that has not yet spread to bone.
Astellas/Theravance's Vibativ (telavancin) for the treatment of adults with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA). This is the first antibacterial medicine to receive a positive CHMP opinion in two years, "albeit in a restricted indication, addressing an increased need for new antibiotics".
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