Drugs

Aldeyra Tussles With FDA on NDA Data

Aldeyra Therapeutics says it is addressing “substantive” late review-cycle concerns raised by FDA on the company’s NDA for reproxalap for treating the signs and symptoms of dry eye disease. During a recent meeting with Aldeyra, FDA stated that “[i]t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry eye indication,” according to a company statement.

“In subsequent communications between Aldeyra and the FDA,” the company continues, “Aldeyra has submitted responses to the FDA that Aldeyra believes to be sufficient to mitigate the identified issues, but the FDA has not directly opined on the sufficiency of the information submitted, has no legal obligation to review the information submitted by Aldeyra, and has indicated that Aldeyra needs to conduct an additional clinical trial to satisfy efficacy requirements.”

As a result of the stalemate, the company believes it may receive a complete response letter before or on the company’s 11/23 review action target date. If so, the company says the letter would include a requirement for it to conduct another clinical trial before the NDA can be resubmitted.

The NDA is based on data from the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis. The company says the trial enrolled 131 allergic conjunctivitis patients and the primary efficacy endpoint was change from baseline in patient-reported ocular itching score on a 0‑4 point scale over a majority of 11 timepoints from 110 to 210 minutes after allergen chamber entry. It says that patients treated with reproxalap reported statistically significant ocular itching score reduction across all 11 prespecified primary endpoint comparisons compared to those treated with a vehicle.

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