GSK Receives Green Light for New CKD Anemia Treatment – With Caveats

The US Food and Drug Administration (FDA) has given the green light to GSK’s daprodustat, now branded as Jesduvroq, for treating anemia related to chronic kidney disease (CKD) in adults. This marks a major milestone for those suffering from this condition, and could potentially provide them with much needed relief.

GSK has made a groundbreaking discovery in the world of anemia treatment – Jesduvroq, the first innovative medicine for anemia in over 30 years. Approved by the FDA, this hypoxia-inducible factor prolyl hydroxylase inhibitor promises to revolutionize the way we treat anemia, bringing hope to millions of people around the world.

Regulators have issued a stern warning for Jesduvroq, citing a heightened risk of death, stroke, heart attack, and blood clots. Not only that, use of the drug also puts patients at a greater risk of major adverse cardiovascular and thrombotic vascular events. It is a reminder to be extra vigilant and to seek medical advice before taking the drug.

Jesduvroq comes with a host of risks, but there is no known safe dose or dosing strategy to mitigate them. With no way to reduce the potential dangers, it’s important to be aware of the risks before taking this medication.

Jesduvroq is a therapy that is specifically tailored to those receiving dialysis treatments for a minimum of four months. It is designed to improve their quality of life and maximize their potential for a successful outcome. Through its unique approach, patients can look forward to enhanced physical, mental and emotional wellbeing.

In October 2022, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (RDAC) showed their support for the approval of a new drug for dialysis-dependent patients, and the FDA quickly followed, granting their approval. This marks an important development in medical care for those receiving dialysis, providing them with an additional option for treatment.

At the time, independent experts determined that the risk of side effects associated with Jesduvroq outweighed its potential benefits, making it an unfavorable choice for those who did not require dialysis treatment.

Despite the potential risks in dialysis patients, the committee felt that the drug’s efficacy was so compelling that healthcare providers could manage any toxicities with the right label warnings. Thus, the drug was approved for this patient population.

The ASCEND clinical program, the focus of the RDAC meeting, presented compelling evidence for the approval of Jesduvroq. This multi-faceted program included five Phase III trials, which together included over 8,000 patients and spanned a period of more than four years. The trials assessed the efficacy and safety of the drug across the entire disease spectrum, and the results were overwhelmingly positive.

One Down, Three to Go

GSK is looking forward to 2023, with four FDA anticipated approvals on the horizon, including Jesduvroq. As revealed in their full-year financial report, the company is optimistic about the potential of these therapies to make a real difference in the lives of patients.

Momelotinib, an oral drug that targets JAK1 and JAK2 signaling as well as the activin A receptor type I protein, could be a game-changer for those suffering with myelofibrosis. The investigational drug is awaiting a regulatory verdict to bring much-needed relief to patients around the world.

In April 2021, GlaxoSmithKline made a $1.9 billion acquisition of Sierra Oncology, and just a few months later, in January 2022, Sierra reported that their drug, momelotinib, met its primary endpoint of total symptom score reduction of over 50% in the Phase III MOMENTUM trial. This is a major breakthrough for Sierra and GSK and could provide invaluable relief to those affected by the disease.

The FDA is set to make a crucial decision on GSK’s respiratory syncytial virus vaccine for older adults. In a pivotal Phase III trial in October 2022, the candidate vaccine demonstrated an impressive overall efficacy rate of 82.6%, proving even more effective in older adults and those with underlying comorbidities. With these promising results, the vaccine may soon become an important tool in protecting the elderly from this virus.

Exciting news for endometrial cancer patients is on the horizon – the potential approval of Jemperli (dostarlimab) is anticipated in the near future. This promising drug could be a major breakthrough for those struggling with this difficult disease, providing much needed relief and a greater chance at recovery.

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