Clinical Intelligence

FDA approves Amgen’s Parsabiv for secondary hyperparathyroidism

Thursday, February 9, 2017

Amgen has announced that the FDA approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic that can be administered intravenously by the dialysis healthcare team three times a week at the end of the hemodialysis session.

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Acorda announces positive phase III CVT-301 results for Parkinson’s

Thursday, February 9, 2017

Acorda Therapeutics has announced phase III clinical data of CVT-301, showing a statistically significant improvement in motor function in people with Parkinson’s disease experiencing OFF periods. CVT-301 is an investigational, inhalable formulation of levodopa (L-dopa). It is being studied as a treatment for OFF periods in people with Parkinson’s disease taking an oral carbidopa/levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms.

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Sanofi’s Xyzal Allergy 24HR FDA approved for over-the-counter use

Thursday, February 2, 2017

The FDA has approved Sanofi’s Xyzal Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and year-round allergies. Specifically, two formulations of Xyzal are now approved for OTC use 5mg tablets for ages 6 years and older, as well as 0.5 mg/mL oral solution for ages 2 years and older. Xyzal is an oral antihistamine with a proven 24-hour effect.

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Audentes’ AT342 Crigler-Najjar Syndrome NDA granted FDA clearance

Thursday, February 2, 2017

Audentes Therapeutics, a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, announced that the FDA has cleared the investigational new drug (IND) application for AT342, the company’s gene therapy product candidate to treat Crigler-Najjar Syndrome. The IND is now active and Audentes plans to initiate VALENS, the multicenter, multinational, open-label, ascending dose phase I/II clinical study of AT342. Preliminary data from VALENS is expected to be available by the end of 2017.

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FDA grants Priority Review for Genentech’s Actemra

Wednesday, February 1, 2017

Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted Priority Review designation for Actemra for the treatment of giant cell arteritis (GCA). The designation is based on the positive outcome of the phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.

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