Theravance/Glaxo’s Breo Ellipta wins FDA go-ahead

May 15, 2013 By Ingrid Mezo

GlaxoSmithKline (NYSE:GSK) and Theravance (NSDQ:THRX) won FDA approval for their co-developed Breo Ellipta inhaler for treatment of airflow obstructions, including bronchitis and emphysema in patients with chronic obstructive pulmonary disease.

The once daily, long-term maintenance inhaler is also indicated to reduce COPD exacerbations in patients with a history of such flare-ups, the companies said.

Breo Ellipta is a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist vilanterol and is delivered to the patient using Theravance’s Ellipta, a new dry powder inhaler.

"The FDA approval of Breo Elipta brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States," Theravance CEO Rick Winningham said in a press statement. "After more than a decade of joint respiratory research and development, the approval is a very important milestone for Theravance and GSK."

Theravance and GlaxoSmithKline anticipate rolling out Breo Ellipta in the U.S. during the third quarter of fiscal 2013. Under previously set terms, FDA approval of Breo Ellipta obligates Theravance to make a milestone payment of $30 million to GSK.

The National Heart, Lung and Blood Institute estimates that as many as 27 million people in the US alone are affected by COPD, a number that is predicted to increase, the companies pointed out.

"This approval means that we can now realize our plan to bring Breo Ellipta to appropriate COPD patients in the U.S.," head of GSK Global Respiratory Franchise Darrell Baker said in a press statement. "We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes. Breo Ellipta will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation."

GlaxoSmithKline and Theravance are also seeking regulatory approval of the inhaler, under the trade name Relvar Ellipta, in Europe and Japan, the companies said.

What’s next for nitinol tubing?
Nitinol’s unique properties have made it the darling of the medical device industry. A novel technique for mechanically joining nitinol to other metal tubing could reduce cost and mitigate risk. Mark Broadley, Viant Nitinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for… […]
Report: Haemonetics’ blood-collection devices could leave particles in donors
A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare… […]
Spinal Elements’ cervical fixation system wins FDA nod
Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation. Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps… […]
How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
Switchback Medical adds ‘sandbox approach’ to device testing
Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
FDA gives certain device makers more time to add UDIs
The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
How is RF technology shaping the future of medtech?
RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]
Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination. As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier… […]