UNITED KINGDOM — Bayer is setting its sights on blockbuster success with its prostate cancer drug Nubeqa (darolutamide), and a significant endorsement from the UK’s National Institute for Health and Care Excellence (NICE) marks another milestone in achieving that goal.
By securing the endorsement from NICE, Bayer has achieved another significant step towards making Nubeqa more widely accessible in the UK market.
Following its approval in November of last year for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), Bayer entered into a collaboration with UK officials to offer the drug, Nubeqa, to eligible patients through an early access program.
Now, with the endorsement from the National Institute for Health and Care Excellence (NICE), in combination with androgen deprivation therapy and the chemotherapy docetaxel, Nubeqa will become accessible to a broader range of patients in England and Wales, as announced by Bayer.
Nubeqa, developed jointly by Bayer and Finnish pharmaceutical company Orion, is an oral androgen receptor inhibitor designed to impede the function of the receptor and inhibit the growth of prostate cancer cells.
It has proven effective as part of combination therapy for patients with mHSPC, as well as for those with non-metastatic castration-resistant prostate cancer who are at a high risk of developing metastatic disease.
The recent approval for Nubeqa in mHSPC in England was based on compelling clinical data from late-stage trials, which demonstrated that the combination treatment significantly reduced the risk of death by 32.5% compared to a placebo.
This endorsement from NICE expands the availability of Nubeqa to more patients, enhancing their treatment options and potentially improving outcomes.
Prostate cancer is a prevalent form of cancer among men, with approximately 47,000 cases diagnosed in England each year.
Of these cases, around 9,000 progress to metastatic prostate cancer, which poses greater challenges in terms of treatment and patient management.
Recognizing the importance of Nubeqa in their portfolio, Bayer has set ambitious goals for the drug.
The company has revised its peak sales projection for Nubeqa to exceed €3 billion (US$3.2 billion), reflecting its commitment to establishing it as a “foundational” therapy for prostate cancer treatment across all stages.
This strategic approach underscores the potential of Nubeqa to make a substantial impact in improving the lives of prostate cancer patients.
While Bayer continues to work toward that objective, Nubeqa is already showing promising growth potential.
During the first quarter of this year, the medication generated sales of €178 million (US$194 million), marking a 134% increase compared to the same period last year.
In the United States, Nubeqa received expanded FDA approval for mHSPC in August 2022, following its initial approval in 2019 for non-metastatic castration-resistant prostate cancer.
Meanwhile, AstraZeneca’s Forxiga, a key growth driver for the company, also received a recent endorsement from NICE.
Specifically, the agency approved the drug for the treatment of symptomatic chronic heart failure with preserved or mildly reduced ejection fraction. This marks the first NICE-recommended treatment for this specific type of heart failure.
In the US, AstraZeneca markets the drug as Farxiga. During the first quarter of this year, Farxiga generated US$1.29 billion in global sales, reflecting a 30% increase compared to the same period last year.
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