Abeona Therapeutics is preparing for the potential launch of pz-cel (prademagene zamikeracel) to treat recessive dystrophic epidermolysis bullosa (RDEB), after the U.S. Food and Drug Administration (FDA) initiated discussions on the medication label and post-marketing requirements, according to a company press release. Last fall, the…

The U.S. Food and Drug Administration (FDA) is pushing back its timeline for a decision on Abeona Therapeutics’ pz-cel (prademagene zamikeracel), saying the agency needs more time to complete its review of the cell therapy for recessive dystrophic epidermolysis bullosa, known as RDEB. A decision by the FDA on…

In children with epidermolysis bullosa (EB) with airway involvement, a new strategy using both cell and gene therapy showed promise in a new study. Specifically, the reintroduction of the LAMA3 gene that codes for part of a protein called laminin 332 restored the ability of cells to form a healthy barrier…

The U.S. Food and Drug Administration (FDA)’s review of pz-cel (prademagene zamikeracel), a gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), is progressing on schedule. The therapy’s developer Abeona Therapeutics announced it had conducted a biologics license application (BLA) mid-cycle meeting with the FDA and the agency…

Healiva and C4U will collaborate to develop a next-generation gene editing therapy — focusing on new technology to correct gene mutations — for epidermolysis bullosa (EB) patients, who are sometimes known as butterfly children for their fragile skin. Combining C4U’s expertise in gene editing technology and Healiva’s…

Treatment with Abeona Therapeutics‘ investigational cell therapy EB-101 led to successful wound healing and eased pain in seven adults with recessive dystrophic epidermolysis bullosa (RDEB) who were followed for up to six years in a clinical trial. “The updated Phase 1/2a results showed safety and durable efficacy…

Abeona Therapeutics has begun its Phase 3 VIITAL trial evaluating EB-101, a gene-corrected cell therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), the company recently announced. An institutional review board at Stanford University approved the start of the pivotal…

Cell therapy with genetically engineered skin grafts requires that collagen type VII be “corrected” in two types of skin cells — keratinocytes and fibroblasts — to be effective against recessive dystrophic epidermolysis bullosa (RDEB), a study in mice has found. Researchers saw that only skin models made of collagen…

EB-101, a cell therapy candidate from Abeona Therapeutics, induced sustained wound healing lasting for three years or more in a large proportion of people with recessive dystrophic epidermolysis bullosa (RDEB), the long-term follow-up of a Phase 1/2 trial shows. Data were detailed at the 77th Annual Meeting of the…