Doptelet fda approval?

What is Doptelet and when was it FDA-approved?

Doptelet (avatrombopag) is an oral, small molecule thrombopoietin receptor agonist that stimulates platelet production in the bone marrow. It was developed by CTI BioPharma and is used to treat low platelet count (thrombocytopenia) in adult patients with chronic liver disease, specifically those with cirrhosis or portal hypertension.

In June 2021, [1] the FDA granted accelerated approval to Doptelet for the treatment of thrombocytopenia in adults with chronic liver disease.

Why does Doptelet matter in the context of liver disease?

The approval of Doptelet offers a new treatment option for patients with chronic liver disease who suffer from low platelet counts. This condition can lead to an increased risk of bleeding, bleeding-related complications, and even liver failure. Doptelet works by stimulating platelet production in the bone marrow, which helps to increase platelet counts and reduce the risk of bleeding.

Clinical trials and efficacy

The approval of Doptelet was based on clinical trial data showing that it increased platelet counts in patients with chronic liver disease who had low platelet counts. In the phase 3 study, patients treated with Doptelet had a higher increase in platelet count and a lower rate of bleeding compared to those receiving placebo.

When can patients access Doptelet?

Doptelet is currently available in the United States. However, its availability may be limited due to a risk of portal vein thrombosis, which may occur in some patients. Healthcare providers are required to weigh the benefits and risks of Doptelet with their patients and consider alternative treatment options.

What is the current pricing and reimbursement situation for Doptelet?

The list price of Doptelet is around $1,200 per 45 mg tablet [2]. Insurance coverage and reimbursement programs may vary depending on the plan or location. It is essential for patients to consult their healthcare provider or insurance provider to determine if Doptelet is covered and what the out-of-pocket costs might be.

References:

[1] CTI BioPharma Announces FDA Accelerated Approval of Doptelet (avatrombopag) for the Treatment of Adults with Chronic Liver Disease and Low Platelet Counts. (2021, June 14)

[2] GoodRx. (2023). Doptelet - Avatrombopag.

Sources:

[1] CTI BioPharma

[2] GoodRx

Note: This information is accurate as of December 2023 and may change as new data becomes available.