The FDA just gave the green light to Nucala (mepolizumab), a new medication that is now an official “add-on” treatment for adults battling chronic obstructive pulmonary disease (COPD) that just isn’t under control.
This is a huge leap forward in helping people with COPD, especially those who suffer from tough flare-ups even when they’re using their usual inhalers. What makes Nucala stand out? It’s the only approved biologic medicine that’s been specifically tested in patients whose blood tests show a certain level of tiny cells called eosinophils (at least 150 cells per microliter). This is a big deal because a whopping 70% of COPD patients in the U.S. who aren’t getting better and keep having flare-ups have this specific eosinophil level.
The FDA’s decision to approve Nucala wasn’t made lightly. It’s backed by solid proof from two major clinical trials, MATINEE and METREX. Both of these studies put Nucala (100 mg given as a shot every four weeks) to the test, adding it to patients’ regular inhaled treatments.
In the MATINEE trial, which was a hot topic at the American Thoracic Society 2025 International Congress, 804 COPD patients with higher eosinophil levels (at least 300 cells per microliter) saw a remarkable drop in their moderate or severe flare-ups. Patients on Nucala experienced far fewer of these debilitating events (0.80 per year) compared to those who got a placebo (a dummy shot, 1.01 per year). That’s like a 21% reduction in flare-ups – imagine the relief! And it gets even better: the study also found that Nucala significantly slashed the number of COPD flare-ups that sent people to the emergency room or into the hospital (by about 35%).
The METREX trial told a similar success story. Patients taking Nucala also saw a clear decrease in their moderate or severe flare-ups (1.40 per year) compared to those on placebo (1.71 per year). Plus, the side effects reported were pretty much the same for both groups, meaning Nucala is generally a safe bet.
Why This is a Game-Changer for Black Americans
The approval of Nucala is particularly impactful for Black Americans, who often carry a heavier burden when it comes to COPD and face unique challenges in healthcare. While the overall number of Black Americans with COPD is similar to White Americans, Black individuals frequently experience worse outcomes, like more frequent emergency room visits and hospital stays because of their COPD. Why is this often the case? Several factors play a role:
- Higher pollution risk: Black communities often grapple with lower access to quality healthcare and greater exposure to pollution and unhealthy indoor air. These tough circumstances can actually make COPD worse and throw up roadblocks to getting effective treatment.
- Processing of cigarette smoke: Research hints that Black Americans might process cigarette smoke differently, which could unfortunately lead to more lung damage. There’s also evidence that Black women, in particular, might have higher rates of COPD even without a history of smoking. This could be due to factors like breathing in secondhand smoke or having chronic asthma.
- Late diagnosis: Due to deep-rooted differences in healthcare, COPD might not be caught as quickly in Black Americans, especially women or those whose lung problems seem less severe. This delay can let the disease progress further before proper treatment starts, upping the chances of severe flare-ups.
- Co-existing health issues: Black Americans with COPD often come with other health issues, like diabetes and high blood pressure. These extra conditions can really complicate COPD management and worsen their overall health.
Nucala offers doctors a new, powerful, and targeted treatment that can truly help bridge the health equity gaps for Black Americans living with uncontrolled eosinophilic COPD. But for this benefit to shine, we must keep working to tear down the systemic barriers to healthcare access, push for early diagnosis, and ensure that groundbreaking treatments like Nucala are available to everyone in Black communities.