Clinical Intelligence

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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ImmunoGen doses first patient in phase III ovarian cancer study

Friday, January 27, 2017

ImmunoGen, a provider of antibody-drug conjugates (ADCs) for the treatment of cancer, has announced that the first patient has been dosed in FORWARD I, the company’s phase III clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a first-in-class, folate receptor alpha (FRα)-targeting ADC.

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Pfizer posts positive phase II C. difficile vaccine results

Friday, January 27, 2017

Pfizer announced that the phase II study evaluating the company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis, by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced by C. difficile (toxins A and B).

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