Johnson & Johnson’s JNJ subsidiary, The Janssen Pharmaceutical Companies announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor, for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
In February 2018, the FDA approved apalutamide for the treatment of men with nmCRPC. Apalutamide is marketed under the trade name of Erleada.
J&J stock has returned 6.6% year to date compared with growth of 11.5% recorded by the industry.
The CHMP’s positive opinion is based on data from the pivotal SPARTAN phase III study. The data from the study showed that Erleada (apalutamide) significantly reduced the risk of metastatis or death by 72% and increased median metastatis-free survival by more than two years in patients with nmCRPC.
Apalutamide was added to J&J’s portfolio through the August 2012 Aragon acquisition. Also, Erleada’s approval has strengthened J&J’s prostate cancer franchise, especially when the approval of key drug Zytiga for the treatment of metastatic CRPC is facing patent challenges. Last month, J&J announced that a New Jersey district court invalidated its patent (patent ‘438) related to Zytiga, opening doors for generic launches of the drug. However, the court said that no commercial launches of generic products may occur before Oct 31. Several companies like Amneal, Apotex, Dr. Reddy’s RDY, Mylan MYL and Teva TEVA, among others, are looking for an FDA approval of their generic versions of Zytiga.
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