Glaxo Submits First Regulatory Application For Daprodustat
Zacks Investment Research | Aug 21, 2019 10:07PM ET
GlaxoSmithKline plc (NYSE:GSK) announced that it has submitted a new drug application for its pipeline candidate, daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, to Japanese regulatory authorities. The company is looking to get the candidate approved for the treatment of renal anemia associated with chronic kidney disease (“CKD”).
This is the first regulatory application submission globally, seeking approval for daprodustat. The regulatory submission is based on data from three phase III studies conducted in Japan, which evaluated the candidate for the treatment of anemia in patients across the spectrum of CKD from stages 3-5. Data from these studies have shown that oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection as measured by mean hemoglobin levels over weeks 40 to 52.
In April, Glaxo industry ’s decline of 2.1%.
In a separate press release, ViiV Healthcare, Glaxo’s HIV subsidiary, announced headline data from phase III ATLAS-2M study of its long-acting, injectable two-drug regimen of cabotegravir plus rilpivirine as a treatment for HIV patients. The study evaluated administration of the combo regimen every eight weeks (two months) compared to every four weeks (one month). Data from the study showed that administration of the combo every two months was non-inferior to administration once every month.
Please note that rilpivirine has been developed by Janssen, a subsidiary of J&J (NYSE:JNJ) , and is marketed under the tradename of Edurant for HIV-1 infection. ViiV Healthcare is a joint venture between Glaxo, Pfizer (NYSE:PFE) and Shionogi Limited.
ViiV Healthcare has submitted regulatory applications in the United States and in Europe for once a month administration of cabotegravir plus rilpivirine regimen for the treatment of HIV-1 infection. In July, the FDA accepted the application under priority review with a decision expected in December 2019.
Meanwhile, ViiV Healthcare also announced the start of the first-ever study — CUSTOMIZE — to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in the real world.
HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, namely Tivicay, Triumeq and Juluca, in its portfolio. The company remains committed to bringing new treatment regimens for HIV patients.
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