AstraZeneca announced on Monday that the European Medicines Agency (EMA) has put forward recommendations to approve Forxiga, its treatment of symptomatic chronic heart failure, and Trixeo Aerosphere for use in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD).
AstraZeneca (AZN) said that 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. Heart failure (HF) is a life-threatening chronic disease in which the heart cannot pump enough blood around the body, affecting 15 million people in the EU, at least half of which have a reduced ejection fraction.
The UK drugmaker said that EMA’s Committee for Medicinal Products for Human Use (CHMP) based its approval recommendation following results from the Phase 2 trial, which showed that the treatment reduced the risk of cardiovascular death or the worsening of heart failure versus placebo by 26%.
The CHMP’s recommendation for the approval of Trixeo Aerosphere, which is a single-inhaler, fixed dose triple-combination therapy, was based on results from a Phase 3 trial in which the treatment showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies over 52 weeks.
The recommendation for approval was also supported by data from another Phase 3 trial. In both trials, the safety and tolerability of Trixeo Aerospherewere consistent with the profiles of the dual comparators.
“Chronic obstructive pulmonary disease is now the third leading cause of death globally and affects approximately one in 10 adults over the age of 40 in Europe,” said AstraZeneca’s Mene Pangalos. “Trixeo Aerosphere has demonstrated strong clinical benefit when compared with dual-combination therapies and this positive recommendation brings us closer to providing a much-needed new treatment to patients in Europe.”
Trixeo Aerosphere is approved in Japan, China and in US patients with COPD. COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.
AZN shares have lost over 6% over the past month as the Phase 2/3 study of its AstraZeneca/Oxford vaccine candidate was put on hold after an adverse event in a single participant from the UK. The trial has been restarted in the UK but is still on hold in the US. (See AstraZeneca stock analysis on TipRanks)
SVB Leerink analyst Andrew Berens recently reiterated a Buy rating on the stock with a $65 price target (23% upside potential) suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca’s shares as well as in the stock of other companies with Covid vaccine programs until the exact nature of the event is clear.
As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.
Overall, AZN scores a Strong Buy consensus from the analyst community with 4 unanimous Buy ratings. Looking ahead, the $77.38 average analyst price target puts the upside potential at a promising 46% in the coming 12 months.
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