AstraZeneca says the US Food and Drug Administration (FDA) wants more clinical data on its dapagliflozin treatment for type 2 diabetes in adults.
Astra is developing the therapy with US firm Bristol-Myers Squibb and says it has already conducted 19 clinical trials with 8000 adults.
The FDA, however, wants more data to assess the "benefit-risk" profile of the drug, which Astra says "includes clinical trial data from ongoing studies and may require information from new clinical trials."
Subscribe to MoneyWeek
Subscribe to MoneyWeek today and get your first six magazine issues absolutely FREE
Sign up to Money Morning
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
AstraZeneca and Bristol-Myers Squibb say they "remain committed to dapagliflozin" and will work with the FDA to provide the data.
AstraZeneca shares have outperformed the FTSE 100 over the last 12 months, gaining 4% against a loss of 5% for the index overall.
BS
-
Review: Trasierra – a yoga retreat in the Spanish hillsFlora Connell joins a yoga retreat at Trasierra, in the Sierra Morena mountains north of Seville
-
How much should I have in emergency savings?When your boiler breaks or your car won’t start, you can find yourself paying a hefty bill. How much should you have in emergency savings to cover unexpected costs?
