Ensifentrine

A chronic obstructive pulmonary disease approval marks Nucala's fifth in the U.S. While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition.Now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. The thumbs-up makes Nucala (mepolizumab) the second biologic approved for the disease and the third new COPD therapy to score approval in the U.S. in less than a year.Notably, the FDA approved Sanofi and Regeneron’s immunology juggernaut Dupixent in the indication in September, while Verona Pharma’s Ohtuvayre received the regulatory all-clear last June. Dupixent and Ohtuvayre aren’t in direct competition given that Ohtuvayre is cleared in patients with persistent shortness of breath, while Dupixent is suited for COPD patients with persistent exacerbations.That said, Nucala and Dupixent will likely butt heads in the space following GSK’s launch, given that Dupixent's label covers a similar eosinophil-high patient population.Eosinophils, which are a type of white blood cell, serve as a biomarker for type 2 inflammation and help determine the risk of COPD exacerbations, GSK explained in a release.  COPD—which includes chronic bronchitis and emphysema—is a progressive inflammatory lung disease that causes breathing problems. The condition is one of the leading causes of death in the U.S. alongside heart disease and cancer. While it is mainly caused by smoking, nonsmokers are also susceptible, according to the Centers for Disease Control and Prevention.Inhaled triple therapies have been around to treat COPD for some time, but many patients on those standard-of-care treatments continue to experience persistent symptoms and exacerbations, GSK has said.In turn, the need for additional treatment options remains crucial, Luke Miels, GSK’s chief commercial officer, said on a media call ahead of the FDA’s decision.The GSK exec described patients in Nucala’s phase 3 Matinee study in COPD as being “maxed out" on standard of care. The trial findings suggest the IL-5 antibody can offer patients a “material improvement” while also keeping them out of the hospital, according to Miels.Sizing up the competition Miels figures Nucala will be an enticing option for doctors treating COPD patients given the breadth of the patients who participated in Matinee.GSK’s phase 3 trial recruited COPD patients with chronic bronchitis, emphysema only or both, which can “sometimes be difficult to separate,” Miels said. Conversely, the late-stage trials that supported Dupixent's COPD approval in September included patients who had chronic bronchitis and emphysema or bronchitis alone, but not emphysema only patients, Miels noted.“We had the widest population, which is important because for a physician to stratify these patients, it’s much simpler to be able to say, ‘OK, I can use Nucala in patients whether they’ve got emphysema, chronic bronchitis or both,’” he explained.GSK is also playing up Nucala’s ability to help COPD patients avoid hospitalization, which often marks a severe turn in a person’s prognosis.Around 1 in 4 COPD patients who are hospitalized end up dying within a year, while roughly half of patients who are hospitalized will likely die within five years, Miels said.“There’s a very high burden when you have severe exacerbations and end up being hospitalized,” Miels said. “So, the aim is to keep patients out of the hospital, keep them stable and keep them at home.”In the Matinee study that helped secure Nucala’s approval, the interleukin inhibitor led to a 21% reduction in the annualized rate of moderate or severe COPD exacerbations versus placebo, hitting its primary endpoint, GSK said in a data drop late last month. GSK’s drug also curbed the annualized rate of moderate or severe exacerbations compared to placebo by 31% in patients who only have chronic bronchitis.Nucala also cut patients’ yearly rate of exacerbations leading to emergency room visits and hospitalizations by 35% in one of the trial’s main secondary endpoints, GSK added.The study found that adverse events were largely on par between Nucala and placebo, with the most common issues patients faced including exacerbation or worsening of their COPD.Matinee specifically assessed Nucala in COPD patients with evidence of type 2 inflammation confirmed via high blood eosinophil count. Nucala's approval was also bolstered by older results from the late-stage Metrex study, which pitted the drug against placebo both in COPD patients with an eosinophilic phenotype and those without. While the indication is new territory for Nucala, GSK is no stranger to COPD and currently boasts the “largest product in COPD today” by way of its triple-therapy inhaler Trelegy Ellipta, Miels said. Nevertheless, the company is planning further outreach and education efforts for both doctors and patients in the wake of Nucala’s FDA nod, Miels said.The COPD approval marks the fifth Nucala has received from the FDA, following green lights in severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.Meanwhile, Thursday's approval came two weeks after the FDA missed its original target decision date for Nucala in COPD. GSK had originally expected to hear a verdict on its filing by May 7. On GSK's media call earlier this month, Miels noted that the company plans to “essentially keep the same pricing structure that we already have” with Nucala, which currently costs around $3,800 for a single dose for injection in the U.S. before discounts. The company expects Nucala to hit 500 million pounds sterling (roughly $669 million) in peak year sales for COPD, Miels noted.For all of 2024, Nucala sales across its prior four indications grew (PDF) by 13% at constant currencies to 3.3 billion pounds ($4.4 billion). The drug generated (PDF) 444 million pounds ($594 million) in 2025’s first quarter, a 21% increase over the sum it delivered for the same period last year. 

Vivo Capital has invested in 430 public and private companies since it was founded in 1996. Image credit: Shutterstock/ Pixelbliss. Set against a backdrop of barren biotech investment, Vivo Capital has secured $740m to back preclinical and clinical-stage life science companies. The funds will be allocated in the latest cycle of the Vivo Opportunity Fund, an evergreen public pot that runs in three-year investment cycles. Unlike traditional funds with a fixed lifespan, evergreen investments occur over periodic intervals. US-based venture capital (VC) company Vivo Capital said the third cycle will follow the same strategy as the first and second, helping finance small- and mid-cap biotechnology and life science companies. According to the financial entity, the investments aim to “capture value from breakthroughs and clinical milestones,” as per a 7 May press release. There are approximately $5.3bn in regulatory assets under management for Vivo Capital, with the business investing in 430 public and private companies globally since it was founded in 1996. The Vivo Opportunity Fund has already catalysed a plethora of medicine development via biotech investments in its first two cycles. Verona Pharmaceuticals, for example, won US Food and Drug Administration (FDA) for its chronic obstructive pulmonary disease (COPD) treatment Ohtuvayre (ensifentrine) in June 2024. Ohtuvayre has been earmarked as ‘transformative’ for the COPD space due to its innovative mechanism of action and limited gastrointestinal side effects. Geron Corporation, Avadel Pharmaceuticals, and Soleno Therapeutics were other companies highlighted by Vivo Capital as gaining FDA approvals for therapies in recent years. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In addition, there are the Vivo Capital-backed biotechs that were acquired by big pharma companies in recent years. The largest was for radiopharmaceutical specialist RayzeBio, scooped up by Bristol Myers Squibb (BMS) for $4.1bn in 2023 . Other deals namechecked by Vivo in the billion-dollar league include Novartis’ acquisition of Chinook Therapeutics for $3.2bn in 2023, GSK’s buyout of Sierra Oncology for $1.9bn in 2022, and Sanofi’s takeover of Kadmon for $1.9bn in 2021. These signify that Vivo Capital has a knack for spotting biotechs with potential, with managing director Kevin Dai saying the firm “looks for the best opportunities across the entire healthcare spectrum”. Dr Gaurav Aggarwal, also a managing director at Vivo Capital, said: “Vivo has been investing in healthcare and life sciences for almost 30 years, demonstrating consistency and supporting innovation across market cycles.” The $740m secured by Vivo Capital comes during a lull in venture capital funding for the biotech scene. Cash has already been in short supply since the boom in 2020 and early 2021, though current macroeconomic pressures have accelerated the funding downturn. US President Donald Trump has also cut government-led funding schemes in the country, removing secondary investment mechanisms that many biotechs rely on . A report by GlobalData demonstrated that biopharma drug company venture financing witnessed a 20.2% downturn in Q1 2025 compared to the same period in 2024. Funding only reached $6.5bn, shy of the $8.1bn invested in Q1 2024. Analysts state that this suggests a preference for investors to back later-stage companies with clinical data already on their books. “Amid the ongoing macroeconomic uncertainty, venture capitalists are favouring opportunities with clearer routes to near-term revenue and market access over longer-horizon development risks,” said Alison Labya, business fundamentals pharma analyst at GlobalData. GlobalData is the parent company of Pharmaceutical Technology.