Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genentech’s Lucentis begins shipping June 30 with price set at premium; wholesale acquisition cost is $1,950 per vial. Bristol-Myers Squibb is positioning its second-line leukemia agent Sprycel as a less expensive option than Novartis’ Gleevec following approval June 28; Celgene’s Revlimid clears FDA for treatment of second-line multiple myeloma
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Genentech Lucentis price set at premium: Genentech's Lucentis (ranibizumab) begins shipping June 30 - the same day FDA clears the biologic for treatment of wet age-related macular degeneration. The VEGF inhibitor received a priority review and will be priced at a premium to other AMD therapies, with a wholesale acquisition cost of $1,950 per vial; Genentech estimates average annual cost per patient will be $9,750-$13,650. Pfizer/OSI's Macugen (pegaptanib) has an annual list cost of $7,960. "Lucentis is the first treatment which, when dosed monthly, can maintain the vision of more than 90% of patients with this type of AMD," FDA said. Lucentis improved vision in 40% of patients in clinical trials, and roughly 95% maintained vision levels without losing additional sight. Labeling recommends administration once monthly.... Bristol positions Sprycel as less expensive leukemia option: Bristol-Myers Squibb is positioning its second-line leukemia treatment Sprycel (dasatinib) as a less expensive option than Novartis' Gleevec (imatinib). The agency approved the oral tyrosine kinase inhibitor June 28 for treatment of chronic myeloid leukemia with resistance or intolerance to prior therapy (including Gleevec), and for treating adults with Philadelphia chromosome-positive acute lymphoblastic leukemia. The clearance follows the Oncologic Drugs Advisory Committee's June 2 unanimous recommendation for approval. Sprycel is approved under Subpart H: Bristol is required to submit follow-up data from ongoing trials to gain full approval for CML.... Revlimid second-line multiple myeloma claim: Celgene's Revlimid (lenalidomide) clears FDA June 29 for treatment of second-line multiple myeloma in combination with dexamethasone. The approval comes with a postmarketing commitment asking the sponsor to submit additional data illustrating that thromboembolic risks linked to Revlimid can be reduced with prophylactic anticoagulant use. FDA approved Revlimid 5 mg and 10 mg last December for treatment of patients with transfusion-dependent anemia due to myelodysplastic syndromes (1 Pharmaceutical Approvals Monthly January 2006, p. 3). The drug will now be offered in 15 mg and 25 mg strengths, and will be available through specialty pharmacies at wholesale acquisition costs of $280 and $295, respectively.... |