Le Lézard
Classified in: Health
Subject: FDA

Camargo client Chiasma receives FDA approval for first and only oral somatostatin analog for long-term maintenance treatment of acromegaly


CINCINNATI, July 2, 2020 /PRNewswire/ -- 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.

SOURCE Camargo Pharmaceutical Services


These press releases may also interest you

at 00:25
Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial...

28 mar 2024
The report titled "Central Lab Market by Service Type (Anatomic Pathology/Histology, Biomarker Services, Genetic Services), Phase (Phase 1, Phase 2, Phase 3), Therapeutic Area, End-use - Global Forecast 2024-2030" is now available on...

28 mar 2024
The report titled "Personalized Nutrition Market by Measurement Type (Active Measurement, Standard Measurement), Application (Indication-based, Standard Supplements), Distribution Channel, End-Use - Global Forecast 2024-2030" is now available on...

28 mar 2024
The report titled "Carbon Dioxide Incubator Market by Product (Air Jacketed CO2 Incubators, Direct Heat CO2 Incubators, Water Jacketed CO2 Incubators), Capacity (100-200 Litre, Above 200 Litre, Below 100 Litre), Application, End User - Global...

28 mar 2024
The "Global Clinical In Vitro Diagnostic Medical Laboratory Services Market: Strategy & Trends with Volume & Price Forecasts by Chemistry, Hematology, Microbiology, Pathology, Covid-19, and Molecular Dx by Country. Updated with Impact of COVID-19"...

28 mar 2024
The "Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Customization 2023 - 2027 " report has been added to  ResearchAndMarkets.com's offering. Infectious disease Dx is...



News published on and distributed by: