FDA Policy/General

Aisa Pharma Orphan Status for Cilnidipine

FDA has granted Aisa Pharma an orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis (SSc), a rare and severe autoimmune disease affecting approximately 175,000 Americans. SSc has the highest mortality rate among autoimmune diseases, according to the company, and it is marked by its debilitating symptoms, including severe pain and compromised organ function.

The designation is based on preliminary data from an ongoing Phase 2 study, which indicates that AISA-021 may offer significant benefits over existing treatments. Aisa Pharma says the study has shown promising results, including improvements in overall disease severity, pain management, gastrointestinal symptoms, skin ulcers, disability, and breathing difficulties. Additionally, the data suggest a lower incidence and severity of side effects compared to current therapies, with improved efficacy in preventing Raynaud’s attacks, it says.

Aisa Pharma says it has scheduled a Pre-IND meeting this month to discuss AISA-021’s development for both SSc secondary Raynaud’s Phenomenon. The company says it is also awaiting further results from initial drug screenings performed by the NIH, which assessed AISA-021’s potential as a non-opioid analgesic and found no evidence of abuse liability or addictive potential.

AISA-021, a form of cilnidipine, is known for its increased selectivity for N-type calcium channels and is already used for hypertension in certain Asian countries, the company 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