On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released.

Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition.

COPD: The third leading cause of death in humans

Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease.

According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from COPD. The prevalence of COPD is expected to increase over the next 40 years, and by 2060 more than 5.4 million people may die from COPD and related diseases each year. A study published by Academician Wang Chen in "The Lancet" in 2018 showed that there are nearly 100 million COPD patients in my country, and the prevalence of COPD in adults over 40 years old reaches 13.7%.

According to the Chronic Obstructive Pulmonary Disease (COPD) market research report released by Burgess Consulting, the global Chronic Obstructive Pulmonary Disease (COPD) market size will be US$21.44 billion in 2023, and the market is expected to grow at 4.3 during the 2023-2028 forecast period. % compound annual growth rate.

COPD drugs start a new round of competition

At present, the main treatments and preventive drugs for COPD include inhaled corticosteroids, bronchodilators, phosphodiesterase-4 inhibitors, antibiotics, vaccines, mucolytic agents and antioxidants. Although these drugs have significantly improved the symptoms of COPD patients, the prevention of acute exacerbations of COPD is still a difficulty in current treatment.

Mepolizumab is an interleukin 5 (IL-5) receptor inhibitor that specifically binds IL-5 and prevents it from activating the IL-5 receptor. It was first approved by the US FDA for severe asthma in November 2015. , the trade name is Nucala. The drug has since been approved for other indications, including chronic sinusitis and hypereosinophilic syndrome.

The MATINEE study was a 104-week, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating Nucala versus placebo as a maintenance therapy for moderate-to-severe COPD with frequent disease exacerbations and elevated blood eosinophil levels. The effectiveness and safety of additional treatment options beyond treatment. The primary endpoint of the study was the annual rate of exacerbation of moderate-to-severe COPD.

The results showed that Nucala plus inhaled maintenance therapy significantly reduced the annual incidence of moderate or severe exacerbations in COPD patients for up to 104 weeks.

In the second quarter of this year, Nucala sales reached 482 million pounds ($634.7 million), a year-on-year increase of 17%. If Nucala can be successfully approved for expanded indications for COPD, future sales are expected to grow further.

But it won't be the only new option.

In June this year, the FDA approved the marketing of Verona Pharma’s Ohtuvayre (ensifentrine), which is the first COPD maintenance therapy with a new mechanism approved by the FDA in more than 20 years. The drug is a small molecule selective dual inhibitor of phosphodiesterase (PDE3/4) with dual bronchodilatory and anti-inflammatory effects.

In July, the European Medicines Agency (EMA) approved Dupixent (dupilumab), developed by Sanofi and Regeneron, as a treatment for uncontrolled chronic obstructive pulmonary disease characterized by elevated blood eosinophil levels. As an add-on maintenance treatment for patients with lung disease (COPD), it has become the first approved biological agent in the treatment of COPD. The drug is also expected to be approved by the US FDA this month, with a PDUFA date of September 27.

In addition, more pharmaceutical companies are developing new drugs for COPD, including Regeneron's IL33 monoclonal antibody itepekimab, AstraZeneca/Amgen's TSLP monoclonal antibody Tezspire (tezepelumab), etc. In addition, many domestic pharmaceutical companies have joined the competition for new COPD drugs, including Chia Tai Tianqing’s PDE3/4 inhibitor TQC-3721, Connoya’s IL-4Rα monoclonal antibody sprucizumab (CM310), etc.

Source: https://news.yaozh.com/archive/44192.html