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The HealthCare unit of Bayer AG ( BAYRY - Analyst Report ) recently announced that the US Food and Drug Administration (FDA) granted priority review to the New Drug Application (NDA) for its oncology candidate radium-223 dichloride (radium-223). Bayer is co-developing radium-223 with Algeta ASA.
Priority review is granted to those medicines that offer major advances in care or provide treatment where there are no existing therapies. The FDA completes the priority review within eight months from the date of the NDA submission rather than the usual 12-month review process.
Bayer had submitted the NDA for the candidate in Dec 12 for the treatment of castration-resistant prostate cancer (CRPC) patients suffering from bone metastases. Radium-223 enjoys fast track status from the FDA for treating CRPC in patients suffering from bone metastases. A final decision from the US regulatory body should be out by Aug 2013.
Bayer’s NDA submission was based on positive results from the phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study on radium-223. Data from the study revealed that treatment with radium-223 resulted in a 44.4% improvement in overall survival and caused a 30.5% reduction in the risk of death compared to patients in the placebo arm.
Moreover, in January this year a licensing decision on the medical use of radium-223 was issued by the US Nuclear Regulatory Commission (NRC). As per the decision the US medical sites can acquire and administer radium-223 under 10 CFR Part 35, Subpart E including 10 CFR § 35.300.
We remind investors that Bayer is also seeking European approval of the candidate. In Dec 2012, the company had submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the treatment of CRPC patients with bone metastases.
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