Roche granted further good news by FDA
pharmafile | October 11, 2016 | News story | Manufacturing and Production | Actembra, Alecensa, FDA, Lucentis, Roche, United States, america
Roche was given further good news by FDA after receiving a Priority Review for its Lucentis drug – this news comes on the back of two Breakthrough Therapy Designations for its Actembra and Alecensa drugs.
In the trial of Lucentis, the Phase III RADIANCE study found that Lucentis provided superior visual acuity gains in people compared to those who had been treated with verteporfin photodynamic therapy, which is currently the only treatment option approved by FDA for treatment of mCNV.
mCNV is a condition in which new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, which can cause irreversible central vision loss.
Being granted Priority Review means that the FDA sets itself a goal of taking action upon drug application in six months, as opposed to 10 months in the standard process. The FDA has granted the Priority Review having deemed Lucentis to be a drug that treats a serious condition and which could provide a significant improvement in safety or efficacy over alternatives. Lucentis would be the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV.
Commenting upon the FDA’s decision, Sandra Horning, M.D., chief medical officer and head of Global Product Development at Roche, said: “With the current FDA-approved therapy, people with myopic choroidal neovascularization achieve only temporary stabilization of vision, while mCNV patients treated with Lucentis in the RADIANCE study experienced significant improvement of their vision…Today’s filing acceptance and Priority Review for Lucentis brings us one step closer to a potential new option for people with this serious eye condition.”
The news adds to a good start to October for Roche, having had the previously mentioned Breakthrough Therapy Designations, as well as successful results in the Phase III of their immunotherapy drug Tecentriq.
Ben Hargreaves
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