19th Oct 2020 08:48
(Alliance News) - AstraZeneca PLC on Monday said it has received positive European regulatory opinions for two of its drugs: Forxiga and Trixeo Aerosphere.
The FTSE 100 drug manufacturer said Forxiga - whose generic name is dapagliflozin and is known in the US as Farxiga - has been recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency as a treatment for symptomatic chronic heart failure in adults with and without type-2 diabetes.
The regulatory body based its opinion on results from the DAPA-HF Phase III trial which demonstrated that Forxiga in addition to standard of care, reduced the risk of death or the worsening of heart failure versus the placebo by 26%.
If approved, Forxiga would become the first SGLT2 inhibitor indicated for heart failure with reduced ejection fraction in patients with and without type-2 diabetes, AstraZeneca explained.
"The unmet need for novel medicines in heart failure remains high, with more than half of patients expected to die within five years of diagnosis. Novel treatment options reducing cardiovascular death and hospitalisation, in addition to improving symptoms, are urgently needed. With the positive opinion for Forxiga we are one step closer to transforming the standard of care for millions of people in the EU living with heart failure," said Mene Pangalos, executive vice president of BioPharmaceuticals research & development at Astra.
Separately, AstraZeneca said Trixeo Aerosphere has also been recommended for marketing authorisation in the EU for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease.
The endorsement of Trixeo Aerosphere was based on results from the ETHOS Phase III trial in which the drug showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere and PT009 over 52 weeks.
Trixeo Aerosphere is already approved as a treatment for COPD under the brand name Breztri Aerosphere in Japan, China and the US.
Shares in AstraZeneca were trading 0.6% higher at 8,262.39 pence each on Monday morning in London.
By Ife Taiwo; [email protected]
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