Camargo Pharmaceutical Services issued the following announcement on July 2.
Camargo Pharmaceutical Services, LLC, congratulates Chiasma, Inc. on obtaining approval from the US Food and Drug Administration for MYCAPSSA® (octreotide) capsules. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA.
On June 26, 2020, the FDA granted approval for MYCAPSSA, the first product approved using Chiasma's Transient Permeability Enhancer (TPE®) technology. The product is indicated for long-term maintenance treatment of acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Acromegaly is a rare chronic disease often caused by a benign pituitary tumor and characterized by excess production of growth hormone and insulin-like growth factor-1 hormone.
Camargo, a leading global partner for product development strategy, regulatory and development solutions, supported Chiasma with first obtaining orphan drug designation for MYCAPSSA and then navigating the complex approval process.
"MYCAPSSA is a welcome and needed option to address many of the treatment challenges faced by patients on injectables with acromegaly," Dr. Ruth Stevens, Camargo's co-founder and chief scientific officer, said. "We are proud to have joined Chiasma in advancing our shared vision to better patients' lives."
"Our 10-year collaboration with Camargo played a key role in achieving this successful milestone," Shoshie Katz, Chiasma's VP of quality assurance and regulatory affairs, said. "Camargo was an integral part of our team, and we are grateful for the contributions and support that Camargo provided."
About Camargo
Founded in 2003, Camargo Pharmaceutical Services is a leading global strategy, regulatory and development partner for emerging biotech. We specialize in complex development programs where no playbook exists, with integrated solutions to reach milestones with speed and capital efficiency.
Camargo has experience in complex development programs and accelerated approval pathways that leverage our core expertise in areas such as the 505(b)(2) pathway, oncology, rare disease, combination products and digital therapeutics. We are proud to support clients in more than 25 countries around the world.
Original source can be found here.
