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Bayer’s Eylea 8mg Makes Huge Regulatory Strides Worldwide: Receives Approval in UK, Days After Japan; Application for Approval Accepted in China

Recent regulatory nods join a string of approvals including the United States and European Union

German pharmaceutical giant Bayer announced Thursday, January 24, 2024 that their application for regulatory approval in China for blockbuster drug Eylea 8mg (aflibercept 8mg) has been accepted for neovascular (wet) age-related macular degeneration (nAMD).

The news comes mere days after Eylea 8mg was approved for use in the UK by the nation’s Medicines and Healthcare products Regulatory Agency (MHRA) on January 22nd. Eylea 8mg was also given the go-ahead by Japan’s Ministry of Health, Labour and Welfare (MHLW) four days earlier on January 18th.

The application was accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) on the merits of the Phase III PULSAR trial data, which has demonstrated unprecedented durability and treatment interval lengths and a safety profile similar to that of Eylea (aflibercept 2mg), one of the current standards in exudative retinal disease control.

“Retinal disease is a significant health issue in China,” said Dr. Christian Rommel, a member of the Executive Committee of Bayer’s Pharmaceuticals Division and head of Research and Development. “For patients living with neovascular age-related macular degeneration, losing visual function substantially impacts their lives. Extended treatment intervals can address this important patient need by reducing the number of injections and alleviating the burden on patients.”

Patients in the PULSAR trial dosed with extended treatment intervals (12 or 16 weeks) showed non-inferior visual acuity after 48 weeks compared with Eylea 2mg at 8 weeks, with 77% of nAMD patients achieving and maintaining 16 week intervals. On average, these patients received only five injections over the period. 

Application acceptance in China quickly follows UK regulatory approval

Eylea 8mg has also received the go-ahead from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for marketing approval in the UK. The announcement came late in the day on January 22nd.

The drug was approved in the UK for the treatment of nAMD and diabetic macular edema (DME) in adults following a bevy of positive short- and long-term data from the PULSAR (nAMD) and PHOTON (DME) trials.1,2 

With aflibercept 8mg treatment intervals in both diseases shown to be extendable to up to 24 weeks with a similar safety profile to aflibercept 2mg, the drug is expected to have a significant impact on current unmet treatment burden needs in exudative retinal diseases.

It is the first treatment for nAMD and DME in the UK authorized for treatment intervals of up to 5 months between injections. These intervals are potentially achievable after 3 initial monthly loading doses and are dependent upon visual and anatomical outcomes. 

According to the NHS, outpatient ophthalmology is the busiest subspecialty in secondary care, representing almost 10% of the country’s appointment backlog.3 

Japan gives Eylea 8mg the green light 

Eylea 8mg’s approval in the UK comes hot on the heels of the same move by Japan’s MHLW on January 18th. The MHLW also approved the drug for treatment of nAMD and DME in adults in the country. 

“The approval of Eylea 8mg marks a significant step in advancing clinical practice of retinal diseases in Japan. Many patients struggle with long-term compliance,” said Satoshi Yamanaka, country medical director and head of Medical Affairs & Pharmacovigilance at Bayer Yakuhin in Japan.

“Eylea 8mg will allow for extended treatment intervals, thus providing sustained disease control with greater and longer lasting control of the underlying disease.This would mean a considerable reduction of disease burden for patients, while also alleviating patient management for physicians,” he concluded. 

Dominoes fall after early stumble

The approval by UK and Japanese authorities is just the latest in a long line of globe-spanning regulatory wins for Eylea 8mg. After a hiccup in the form of a Complete Response Letter (CRL) from the FDA in June 2023 related to third-party filler Catelent, it’s been smooth sailing for the blockbuster drug ever since. 

The drug, which Regeneron has the exclusive rights to in the US and is marketed as Eylea HD, shook off the CRL and received FDA approval on August 18, 2023. This was followed by the EU earlier this month on January 8th, 2024. The drug is now approved for nAMD and DME in the US, EU, Switzerland, Japan, the UK and the UAE.  

References

  1. Regeneron Press Release. Two-Year PULSAR Trial Results For Aflibercept 8mg Demonstrate Durable Vision Gains At Extended Dosing Intervals in Wet Age-Related Macular Degeneration. Available at: https://investor.regeneron.com/news-releases/news-release-details/two-year-pulsar-trial-results-aflibercept-8-mg-demonstrate. Accessed on 24 January 2024.
  2. Regeneron Press Release. Two-Year Results For Aflibercept 8mg Pivotal Photon Trial Demonstrate Durable Vision Gains At Extended Dosing Intervals in Diabetic Macular Edema. Available at: https://investor.regeneron.com/news-releases/news-release-details/two-year-results-aflibercept-8-mg-pivotal-photon-trial. Accessed on 24 January 2024.
  3. NHS Press Release. New NHS measures to improve eye care and cut waiting times. Available at: https://www.england.nhs.uk/2023/05/new-nhs-measures-to-improve-eye-care-and-cut-waiting-times/. Accessed on 24 January 2024.
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