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With FDA nod, Verona's Ohtuvayre is set to Jack up the COPD market

2024-06-26

临床结果临床3期上市批准

Patients with chronic obstructive pulmonary disorder in the U.S. have the first treatment option with a novel mechanism of action in more than a decade after the FDA signed off on Verona Pharma’s Ohtuvayre.

Thirteen yearschronic obstructive pulmonary disorderll looms as an innovative force in healthcare. Wednesday, when the FDA approved Verona Pharma’s Ohtuvayre (ensFDAntrine) to treaVerona Pharmatructive pulmonary disorder (COPD), it was a reminder of the extraordinary touch Jack had in creating treatments for respiratory disorders.

The pharmacologist, who was born 100 years ago, discovered ensifentrine four decades ago when he was the R&D chief at GFDA The compoVerona Pharmawn Ohtuvayre, ensifentrine make its mchronic obstructive pulmonary disorder (COPD)respiratory disorders

Nineteen years after Verona was established to unlock ensifensifentrinetential—and after RPL554 has undergone nearly 2GSKlinical trials in COPD—Verona RPL554nally pushed Ohtuvayre across the finish line as the first commercial product for the London-based company.

Ohtuvayre becomes the first novel treatment advance inensifentrine decade for COPD, an inRPL554tory condition that restricts airflow from tCOPDungs and leaves patients struggling to breathe. Ohtuvayre is approved as a monotherapy or as an add-on medicine with current therapies.

Ohtuvayrective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodieCOPDase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its abiOhtuvayreoth open the airways of patients and reduce their inflammation.

“It’s really the first novel mechanisphosphodiesterase 3 (PDE3) overphosphodiesterase 4 (PDE4) enzymeselOhtuvayrea’s CEO, said in an interview with Fierce Pharma. “We believe COPDbronchodilator and non-steroidal anti-inflammatory activity has the potinflammationange the treatment paradigm.”

Ohtuvayre is administered twice daily by a jet nebulizer, with sessions lasting beCOPDn five minutes and seven minutes. Verona Chief Commercial Officer Chris Martin said the company doesn’t expect the administration method to affect uptake much as roughly half of COPD patients already use hand-held devices.

Ohtuvayre them for chronic maintenance and a lot of patients use them for rescue. These patients are extraordinarily comfortable with using a nebulizer,” Martin said. “Unfortunately, with many of these patients, their [physical] activity levels are so much lower tCOPDyours or mine, that a nebulization is not a big burden on their [daily] activities.”

Therapies commonly used to control COPD are inhaled corticosteroids, which reduce inflammation, and bronchodilators, which relax muscles in the lungs and widen the airways. Bronchodilators include long-acting beta agonists (LABAs) and long-acting muscarinic agonists (LAMAs). Some COPD patients are on a regimen with all three treatments. Others, who can’t take corticosteroids, use a LAMA and LABA mix.

“One of the things that’s been realCOPDxciting in the research is the idea that painflammationimes are a little nervous about steroids,” Martin said. “This non-steroidal bronchodilator, non-steroidal anti-inflammatory is extraordinarily appealing to them.”COPD LAMA LABA

Two clinical trials have shown that Ohtuvayre performs well alone or along with current maintenance therapies. The drug is most effective on patients who are still symptomatic after using a LAMA and LABA combo.

The phase 3 ENHANCE-I and ENHANCE-IIOhtuvayreet their primary endpoints by showing that Ohtuvayre improved lung function. Pooled analysis of the two studies also showed that Ohtuvayre reduceLAMAare-uLABAhrough 24 weeks by 40% in patients with moderate to severe COPD.

Verona will charge $2,950 for a monthly dose of Ohtuvayre. The $35,400 annual price exceOhtuvayreost-effectiveness threshold (PDF) of between $7,500 and $12,700 per year estaOhtuvayrey The Institute for Clinical Economic Review (ICER), which assesses the value oCOPDarmaceutical products.

“Current evidence shows that ensifentrine decreaOhtuvayrerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” David Rind, M.D., ICER’s chief medical officer, said in a release.

Verona plans to launch Ohtuvaensifentrinehird quarter of this year. The date will be significant as Regeneron and Sanofi are expected to land a highly anticipated approval for Dupixent to treat COPD, with a delayed FDA target decision date of Sept. 27. The companies were originally expecting a verdict on June 27, but it was pushed back three months as regulators asked for additional data on two trials that have set Dupixent up for approval.

Three months ago, analysts at Evercore ISI projected that a COPD nod would add a potential sales booRegeneron5 bilSanofinnually for Regeneron and Sanofi’s megablockbuster, brinDupixent peak saleCOPDtential to $20 biFDAon.Dupixent

As for Ohtuvayre, analysts see it achieving blockbuster statCOPDuickly, with GlobalData estimating sales to reach $1.05 billion by 2Regeneron Sanofi

It’s a recognition of the unmet need in the indication and the massive population that a differentiated treatment could serve. In the U.S., 8.6 million patients are treated for chronic symptoms of COPD. More than 390 million people worldwide are living with COPD.

“We believe the indication for ensifentrine is broad. It allows the physician to use it across that 8.6 million spectrum,” Martin said. “What we hear in our research is that doctors are looking forCOPD therapeutic options for patients who are persistently syCOPDmatic. What we see across a variety of different studies is at least half the patients treated today remain persistently symptomatic and are dissatisfied with current therapies.”

A fixed-dose combination of Ohtensifentrinehe LAMA glycopyrrolate is currently under development for the maintenance treatment of COPD. Ohtuvayre also has potential to be developed for cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases.

With a market cap of $1.27 bOhtuvayred an FDA-LAMAoglycopyrrolateerona could be viewed as a potential buyout target, and GSK wouldCOPDa Ohtuvayre given its experience with respiratory dcystic fibrosistsnon-cystic fibrosis bronchiectasisriasthmaifentrine frespiratory diseasesthe company where it was established by Jack, who also discovered blockbuster asthma drug Advair and the first inhaled steroid beclomethasone.

EDITOR'S NOTE: The price Verona is charging for Ohtuvayre was added to the story.GSK respiratory disease ensifentrine asthma beclomethasone