| |AUGUST 20248SANDOZ RECEIVES US FDA NOD FOR ENZEEVU TO IMPROVE VISUAL ACUITYAVALYN ANNOUNCES INITIATION OF PHASE 1B CLINICAL TRIAL FOR AP02The US FDA has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection by Sandoz, the leading company in generic and biosimilar medicines worldwide. Enzeevu is recommended for enhancing and preserving vision in individuals with neovascular age-related macular degeneration (nAMD). Additionally, the FDA has tentatively decided that Enzeevu can be used interchangeably with the reference medication due to its unexpired exclusivity for being one of the first interchangeable biosimilar products.Enzeevu is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements. nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.Jeff Todd, J.D., president and CEO of Prevent Blindness, said: "As sight disappears, so may a person's connection to the world. We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable". POAvalyn Pharma Inc., a biopharmaceutical company in the clinical stage that specializes in developing inhaled treatments for severe pulmonary diseases, has started a Phase 1b clinical trial to assess the safety, tolerability, and pharmacokinetics of AP02 (inhaled nintedanib) in healthy adult volunteers, using both single and multiple ascending doses.AP02 is a new version of inhaled nintedanib designed specifically to focus on the lungs. During a Phase 1a trial of AP02 in healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF), AP02 was found to be well-tolerated with no serious adverse events (SAEs) reported and exhibited lower systemic exposure than oral nintedanib."The initiation of this AP02 study marks an important milestone for Avalyn, bringing us closer to delivering a potential new inhaled therapy to patients with pulmonary fibrosis, who are in urgent need of safe and effective treatments that they can tolerate for long-term management of their disease," said Lyn Baranowski, CEO of Avalyn. "We're excited to build on our completed Phase 1a study of AP02 and assess its pharmacokinetic profile to inform our future clinical studies. The Phase 1b study, which is randomized, double-blind, and placebo-controlled, aims to assess the safety, tolerability, and pharmacokinetics of AP02 in healthy adult volunteers. The main focus of the research is the occurrence, rate, and intensity of adverse events (AEs). Other outcomes to be measured are various pharmacokinetic parameters assessed through blood and bronchoalveolar fluid samples. POTOP STORIES
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