Drugs

Aurinia Pharma Moves Into Phase 3 with Lupus Drug

Aurinia Pharmaceuticals says it has received positive FDA feedback to plan a single Phase 3 clinical trial for voclosporin and its use in treating lupus nephritis (LN). The encouragement came from the CDER Division of Pulmonary, Allergy and Rheumatology Products during an end-of-Phase 2 meeting, the company says.

The Phase 3 AURORA trial will be a global 52-week double-blind, placebo controlled study in about 320 patients. Aurinia says it is finalizing the study protocol and regulatory submissions and in parallel is working on site selection with trial initiation expected in the second quarter of 2017. “The study population will be comprised of patients with biopsy-proven active LN who will be evaluated on the primary efficacy endpoint of renal response at 24 weeks,” it says.

“The readout of the primary endpoint of renal response at 24 weeks will occur after database lock at 52 weeks at which point the company intends to submit an NDA,” Aurinia says. “Patients completing the 52-week study will then have the option to roll-over into a 104 week blinded continuation study. These data will allow the company to assess long-term outcomes in LN patients that will be valuable in a post-marketing setting in addition to future interactions with various regulatory authorities.”

Voclosporin is described by the company as a calcineurin inhibitor — an immunosuppressant with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care. “By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome