Diabetes Drug Bydureon Wins FDA Approval

Amylin's Bydureon diabetes drug has won approval from US regulators.
The US FDA approved Amylin's once-weekly diabetes drug Bydureon late Friday.
Bydureon, a glucagon-like peptide-1 receptor agonist, is an extended-release formulation of Amylin's Byetta, utilising Alkermes' long-acting technology.
Bydureon had twice been rejected by the FDA, with the administration seeking more data as to how the drug affects the heart despite it receiving European approval in June 2011.
The FDA approval does, however, come with a risk evaluation and mitigation study, noting that any benefits of the drug should be put against increased risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma.
Related News
-
News Bringing the pharmaceutical supply chain closer to home
The pharmaceutical supply chain has encountered numerous disruptions in the last few years, impacting procurement, manufacturing, packaging, and distribution operations within the pharmaceutical industry. Read about the rise in calls for near/resh... -
News Women in Pharma: Advancing gender diversity & healthcare equality
In our new monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News Humira biosimilars at discounted prices to meet market demand for accessible treatment
Several biosimilars to AbbVie’s monoclonal antibody therapeutic Humira were launched by various pharmaceutical giants this week in the US, with more expected to be released by the end of the year as the patent expires. -
News Women in Pharma: Gearing up for systemic change
In our new monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News Delivering on mRNA-based therapeutics: innovations in applications and packaging
Since the onset of the COVID-19 pandemic, the innovative potential of mRNA vaccines and therapeutics has raised questions regarding their manufacturing, packaging, and storage/transportation. Learn about how the pharmaceutical supply chain is meet... -
News Novavax will provide adjuvant Matrix-M for vaccine research with 3-year partnership
Novavax, developers behind the Matrix-M adjuvant, have entered into an agreement with the Bill and Melinda Gates Medical Research Institute to provide the adjuvant in preclinical vaccine research. -
News CPHI Online Webinar Series – The CPO Perspective: Driving Healthcare Sustainability
Pharmaceutical contract packaging organisations (CPOs) offer organisations broader expertise in pharma packaging, specialist skills, and flexibility with time, efficiency, and costings for pharmaceutical companies lacking in-house packaging expert... -
News The CPO Starter Pack: Why and When to Bring in a Contract Packaging Partner
Discover the trends affecting the pharmaceutical CPO market, when and why outsourcing may be an enticing option, and what is driving pharmaceutical companies and CDMOs to partner with outsourced packaging and drug delivery organisations. ...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance