AstraZeneca PLC (LON:AZN) investors got a double dose of news on Monday after the UK pharma giant received approval from US authorities for a new formulation of its diabetes drug, while it also submitted a new drug application for Lynparza in Japan.
Starting with Bydureon – a single-dose auotinjector device used by diabetes patients once a week – Astra said the US Food and Drug Administration has given it the green light.
The new formulation, which the FTSE 100 group said reduces blood sugar levels and has the added benefit of weight loss – will be available to US patients from the first quarter of 2018.
The European Medicines Agency has also accepted an application for the drug, Astra said.
“With the approval of Bydureon BCise, we're now introducing a new formulation in an improved, easy-to-use device that will help enhance the patient experience,” said executive VP North America Ruud Dobber.
As for Lynparza – one of the company’s growing portfolio of cancer-fighting drugs – AstraZeneca has submitted a new drug application for its use in certain breast cancer patients.
The NDA comes after the positive results from the company’s phase III OlympiAD trial earlier this year.
Lynparza is already under review in Japan for use in ovarian cancer, which Astra should hear back about in the first half of next year.
The review into its use in breast cancer will take a bit longer, with company expecting a response at some point in the second half of 2018.
Shares I nthe drugs giant were 0.4% higher at £51.80 in early deals on Monday.