Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene and cell therapies, and consumer health products, welcomes the announcement by Blueprint Medicines Corporation that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
Catalent’s Nottingham U.K. facility has supported Blueprint Medicines’ development program since 2015, from formulation development, clinical product supply and now commercial supply of AYVAKIT.
“We are delighted to help support Blueprint Medicines with commercial supply for this important medicine, recently approved by the FDA, which provides a new treatment option for patients with this disease,” commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “We have built a global network of development and clinical and commercial supply centers with the specific skills and expertise to help innovators like Blueprint Medicines meet challenging milestones for important novel therapies such as this.”
Jeff Albers, Chief Executive Officer of Blueprint Medicines, added, “We thank the entire Catalent Nottingham team for their continued support these past four years in helping us rapidly develop this important advancement in precision therapy and make a significant difference for patients with high medical needs.” AYVAKIT and Blueprint Medicines are trademarks of Blueprint Medicines Corporation.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.