- In September 2024, the U.S. FDA granted orphan drug designation to AISA-021, a calcium channel antagonist developed by Aisa Pharma, Inc., for the treatment of systemic sclerosis (SSc). This designation provides incentives such as tax credits, grants, and seven years of market exclusivity following drug approval. AISA-021 has shown promising results in ongoing phase 2 studies, demonstrating improvements in symptoms of overall disease severity, disease-related pain, gastrointestinal dysfunction, skin ulcers, disability, and breathing symptoms
- In October 2023, the U.S. Food and Drug Administration (FDA) approved Kyverna Therapeutics' investigational new drug (IND) application, allowing the company to begin the Phase I/II KYSA-5 trial of KYV-101 for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). KYV-101 is a novel, fully human CD19 CAR T-cell therapy designed to target B cell-driven autoimmune diseases. This approval marks a significant step forward in developing new treatment options for patients suffering from this chronic and debilitating condition
- In July 2022, Aisa Pharma Inc. announced positive results from its phase-2 study of Profervia, an oral calcium-channel antagonist, for the treatment of scleroderma. The Data Safety Monitoring Board (DSMB) reviewed the first phase of the study and recommended continuing to the next stage, citing no safety concerns and encouraging early efficacy trends. The study aims to reduce the frequency, severity, and duration of Raynaud's attacks, which are common in scleroderma patients, and improve other symptoms of the disease
- In April 2022, aTyr Pharma, Inc. received USFDA approval for efzofitimod, a treatment for systemic sclerosis. Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2 (NRP2). This approval marks a significant milestone in the treatment of systemic sclerosis, providing a new therapeutic option for patients suffering from this chronic, progressive autoimmune diseaseWhat is the current market size of the global scleroderma therapeutics market?
Frequently Asked Questions
Companies such as Emerald Health Pharmaceuticals(U.S.), Argentis Pharmaceuticals, LLC (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), AbbVie Inc. (U.S.), Pfizer Inc. (U.S.) are the major companies in the global ophthalmic knives market.
The countries covered in the global scleroderma therapeutics market are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, rest of Middle East and Africa, Brazil, Argentina, and rest of South America.
