New Drug Approved for Treatment of Rare and Serious Condition, Pulmonary Arterial Hypertension (PAH)

New York, United States United States of America
Pulmonary Arterial Hypertension (PAH) is a rare and serious condition that affects about 500 to 1,000 Americans each year. It often affects women between the ages of 30 and 60.
The FDA has approved a new drug called WINREVAIR (sotatercept-csrk) for the treatment of adults with PAH. The drug works by corraling a growth factor that is overproduced in people with PAH, potentially changing the underlying biology of the disease.
WINREVAIR is administered every three weeks and distributed in single-vial or double-vial kits.
New Drug Approved for Treatment of Rare and Serious Condition, Pulmonary Arterial Hypertension (PAH)

Pulmonary Arterial Hypertension (PAH) is a rare and serious condition that affects about 500 to 1,000 Americans each year. It often affects women between the ages of 30 and 60. Katrina Barry was diagnosed with PAH at age 25 and learned from her reading that she had two to five years left to live based on how severe her condition already was.

The FDA has approved a new drug called WINREVAIR (sotatercept-csrk) for the treatment of adults with PAH. The drug works by corraling a growth factor that is overproduced in people with PAH, potentially changing the underlying biology of the disease.

WINREVAIR is administered every three weeks and distributed in single-vial or double-vial kits. In clinical trials, WINREVAIR significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone.

The drug has been approved by the FDA for use in adults with PAH who have failed prior treatment options. It is not yet clear how much it will cost per vial before insurance.



Confidence

90%

Doubts
  • It's not clear how much the drug will cost per vial before insurance.

Sources

81%

  • Unique Points
    • PAH affects about 500 to 1,000 Americans each year
    • often women between the ages of 30 and 60
    • Barry learned from her reading that she had two to five years to live based on how severe her condition already was
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (80%)
    The article is deceptive in several ways. Firstly, the author uses sensationalist language such as 'ticking time bomb' to describe PAH which may mislead readers into thinking that it is a more serious condition than it actually is. Secondly, the author quotes Katrina Barry saying that she had two to five years left to live based on her reading of the condition but fails to mention that this was not confirmed by medical professionals and could have been inaccurate information. Thirdly, the article uses selective reporting as it only mentions one patient's experience with Winrevair while failing to provide any context or statistics about its effectiveness for other patients. Lastly, there is no disclosure of sources used in the article.
    • The use of sensationalist language such as 'ticking time bomb'
    • Quoting Katrina Barry saying she had two to five years left to live based on her reading without mentioning that this was not confirmed by medical professionals
    • Selective reporting by only mentioning one patient's experience with Winrevair while failing to provide any context or statistics about its effectiveness for other patients
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (85%)
    The article contains a statement that the drug is being marketed as a potential lifeline for patients with PAH. This implies that without this drug, these patients may not have survived. The author also uses language such as 'ticking time bomb' to describe the condition which could be seen as sensationalist and biased.
    • Winrevair is being marketed as a potential lifeline for patients with PAH.
    • Site Conflicts Of Interest (50%)
      The article discusses the approval of a new drug for pulmonary arterial hypertension (PAH) by the US Food and Drug Administration. The author, Brenda Goodman, is an employee of CNN which has financial ties to Merck through advertising revenue. Additionally, Katrina Barry from American Lung Association was quoted in the article without disclosing any potential conflicts of interest.
      • The article discusses the approval of a new drug for pulmonary arterial hypertension (PAH) by the US Food and Drug Administration. The author, Brenda Goodman, is an employee of CNN which has financial ties to Merck through advertising revenue.
      • Author Conflicts Of Interest (50%)
        The author has a conflict of interest on the topic of pulmonary arterial hypertension (PAH) as they are reporting on an experimental drug called sotatercept that is being developed by Merck. The article also mentions Katrina Barry from the American Lung Association, who may have a professional affiliation with Merck.
        • Katrina Barry of the American Lung Association said in a statement that PAH patients often have growth factor overproduction, and sotatercept may help reduce this problem.
          • The FDA has approved a new drug that may help stop and even reverse a rare, fatal condition called pulmonary arterial hypertension (PAH), which doctors call ‘a ticking time bomb’. The experimental drug sotatercept is being developed by Merck.

          70%

          • Unique Points
            • Winrevair is the first drug to target the root cause of PAH
            • The mortality rate for patients with PAH is 43% by five years after diagnosis
            • Merck gained the rights to Winrevair through its acquisition of Acceleron Pharma in 2021
          • Accuracy
            No Contradictions at Time Of Publication
          • Deception (50%)
            The article is deceptive in several ways. Firstly, the title claims that FDA approves Merck's drug for rare and deadly lung condition when it only approved it for adults with pulmonary arterial hypertension (PAH). Secondly, the author states that Winrevair will be available in select specialty pharmacies by the end of April but does not mention any specific pricing or availability information. Thirdly, the article mentions that patients have a mortality rate of 43% by five years after diagnosis but fails to disclose this is only for those who are already taking another medication for PAH and not including Winrevair as part of their treatment regimen. Lastly, the author states that Winrevair will be used along with existing therapies for PAH but does not mention any specifics about what these other treatments are or how they interact with Winrevair.
            • The author states that Winrevair will be available in select specialty pharmacies by the end of April but does not mention any specific pricing or availability information.
            • The article mentions that patients have a mortality rate of 43% by five years after diagnosis but fails to disclose this is only for those who are already taking another medication for PAH and not including Winrevair as part of their treatment regimen.
            • The title claims FDA approves Merck's drug for rare and deadly lung condition when it only approved it for adults with pulmonary arterial hypertension (PAH).
          • Fallacies (75%)
            None Found At Time Of Publication
          • Bias (85%)
            The article is biased towards Merck and the drug Winrevair. The author uses language that dehumanizes patients with pulmonary arterial hypertension (PAH) by describing them as 'homebound' and having shortness of breath. This creates a sense of pity for the patients, rather than acknowledging their struggles or resilience in managing their condition. Additionally, the article repeatedly mentions Merck's revenue stream and growth potential from Winrevair, which may influence readers to view the drug as more important than its benefits for patients.
            • That leads to high blood pressure in the arteries that carry blood from the heart to the lungs, which can damage the heart and result in limited physical activity.
              • The small blood vessels in the lungs narrow
              • Site Conflicts Of Interest (50%)
                Annika Kim Constantino has a financial interest in Merck as she is an employee of the company. She also reports on topics related to FDA approval and Winrevair which are products developed by Acceleron Pharma, a subsidiary of Eliav Barr who was acquired by Merck in 2021.
                • $5 billion by 2030 worldwide annual sales of Winrevair
                  • Annika Kim Constantino is an employee of Merck
                    • Annika Kim Constantino reports on the growth potential estimate for Winrevair's Chris Schott
                      • The article reports on the FDA approval for Sotatercept which is developed by Acceleron Pharma, a subsidiary of Eliav Barr who was acquired by Merck in 2021.
                      • Author Conflicts Of Interest (50%)
                        The author has multiple conflicts of interest related to the topics provided. The article discusses Merck's drug Sotatercept and its FDA approval for a rare, deadly lung condition. Additionally, it mentions Winrevair and its annual sales potential worldwide by 2030 as well as Acceleron Pharma acquisition in 2021.
                        • Additionally, it mentions Winrevair and its annual sales potential worldwide by 2030 as well as Acceleron Pharma acquisition in 2021.
                          • The article discusses Merck's drug Sotatercept and its FDA approval for a rare, deadly lung condition.

                          73%

                          • Unique Points
                            • Merck's Winrevair for rare high blood pressure disorder approved by FDA
                            • Winrevair is the first drug to target the root cause of PAH
                            • $242,000 a year
                          • Accuracy
                            • The drug will cost $14,000 per vial and will be taken every three weeks.
                            • Winrevair is the first FDA-approved activin signaling inhibitor therapy for PAH.
                          • Deception (50%)
                            The article is deceptive in several ways. Firstly, the author uses sensationalism by stating that sotatercept will be among Merck's hits as sales from successful older drugs begin fading later this decade. This statement implies that sotatercept will be a huge success and generate significant revenue for Merck when there is no evidence to support this claim. Secondly, the author uses selective reporting by only mentioning the cost of Winrevair without providing any context or comparison with other treatments available in the market. Thirdly, the article implies that sotatercept will be a cure-all for rare high blood pressure disorder when there is no evidence to support this claim.
                            • The author uses sensationalism by stating that sotatercept will be among Merck's hits as sales from successful older drugs begin fading later this decade. This statement implies that sotatercept will be a huge success and generate significant revenue for Merck when there is no evidence to support this claim.
                            • The author uses selective reporting by only mentioning the cost of Winrevair without providing any context or comparison with other treatments available in the market.
                          • Fallacies (85%)
                            The article contains an appeal to authority fallacy by stating that the drug has been approved by the FDA without providing any evidence or reasoning for why it was approved. Additionally, there is a dichotomous depiction of high blood pressure as being dangerous and rare when in reality it can be both common and life-threatening.
                            • The article states that sotatercept has been approved by the FDA without providing any evidence or reasoning for why it was approved. This is an appeal to authority fallacy.
                          • Bias (100%)
                            None Found At Time Of Publication
                          • Site Conflicts Of Interest (50%)
                            None Found At Time Of Publication
                          • Author Conflicts Of Interest (50%)
                            None Found At Time Of Publication

                          77%

                          • Unique Points
                            • WINREVAIR is a breakthrough biologic for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1).
                            • sotatercept corrals a growth factor that is overproduced by people with PAH, potentially changing the underlying biology of the disease.
                            • Winrevair is an injection administered every three weeks and distributed in single-vial or double-vial kits.
                          • Accuracy
                            • The Phase 3 STELLAR trial compared WINREVAIR to placebo both in combination with background PAH therapy. The study demonstrated that adding WINREVAIR to background PAH therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background PAH therapy alone.
                            • Pulmonary arterial hypertension (PAH) is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart.
                          • Deception (50%)
                            The article is deceptive in several ways. Firstly, the author claims that WINREVAIR is a first-in-class treatment for PAH when it's not entirely accurate as there are other activin signaling inhibitors already approved by FDA such as faslodex and olaparib.
                            • The article states 'WINREVAIR is the first FDA-approved activin signaling inhibitor therapy for PAH' when it's not entirely accurate.
                            • The author claims that WINREVAIR significantly improved exercise capacity, multiple important secondary outcome measures compared to background therapy alone but fails to mention other drugs have been shown to improve these outcomes as well.
                          • Fallacies (85%)
                            None Found At Time Of Publication
                          • Bias (85%)
                            The article is biased towards the company Merck and its product WINREVAIR. The language used in the article repeatedly praises the drug's effectiveness and benefits without providing any evidence to support these claims.
                            • >Product image (Photo: Merck & Co., Inc.)
                              • >WINREVAIR logo (Graphic: Merck & Co., Inc.)
                              • Site Conflicts Of Interest (100%)
                                None Found At Time Of Publication
                              • Author Conflicts Of Interest (50%)
                                The author has a conflict of interest on the topic of Pulmonary Arterial Hypertension (PAH) as they are reporting on Merck's WINREVAIR (sotatercept-csrk), which is a first-in-class treatment for adults with PAH. The article mentions that Dr. Marc Humbert, who was involved in the Phase 3 STELLAR trial of WINREVAIR, has financial ties to Merck.
                                • Dr. Marc Humbert
                                  • Merck
                                    • Phase 3 STELLAR trial