October 18, 2021

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PAH: FDA approved Johnson & Johnson’s Uptravi intravenous preparation

PAH: FDA approved Johnson & Johnson's Uptravi intravenous preparation

New drug for pulmonary arterial hypertension (PAH)! The US FDA approved Johnson & Johnson’s Uptravi intravenous preparation: for patients who cannot be taken orally temporarily!

 

PAH: FDA approved Johnson & Johnson‘s Uptravi intravenous preparation.  Uptravi intravenous preparations will ensure that patients who are temporarily unable to take oral administration can maintain uninterrupted treatment.

 

PAH: FDA approved Johnson & Johnson's Uptravi intravenous preparation

PAH (Image source: narayanahealth.org)

 

Johnson & Johnson (JNJ)’s Janssen Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) intravenous injection (IV), It is used to treat adult patients with pulmonary arterial hypertension (PAH, WHO group I) who are currently prescribed oral therapy but temporarily unable to receive oral therapy and WHO functional classification II-III.

In patients with PAH, due to the progressive nature of the disease, interruption of treatment should be avoided. The new preparation approved this time allows uninterrupted treatment for PAH patients who are temporarily unable to take oral treatment.

 

Uptravi is a selective prostacyclin IP receptor agonist. Uptravi tablets were first approved by the US FDA for the treatment of PAH in 2015 to delay disease progression and reduce the risk of hospitalization due to PAH. Uptravi IV is a treatment option that allows patients to avoid short-term treatment interruptions and enables patients to continue treatment with Uptravi.

 

Ensuring uninterrupted treatment is critical for patients with PAH. Because even the relatively short-term interruption of PAH treatment due to the temporary inability to take oral medications will have a significant negative impact on the health of patients, studies have confirmed that continuous Uptravi treatment can significantly improve the long-term prognosis of patients. Using Uptravi IV to prevent interruption of Uptravi treatment is an important treatment option for patients with PAH.

 

This approval is based on the results of a prospective, multicenter, open-label, single-sequence crossover Phase 3 study (NCT03187678). The study was carried out in 20 patients to evaluate the safety and tolerability of PAH patients switching from a stable dose of Uptravi tablets to a corresponding dose of Uptravi IV, and then back to the initial dose of Uptravi tablets.

The results show that when oral Uptravi tablets are not feasible, Uptravi IV is suitable for maintaining short-term continuous dosing treatment. The conversion between Uptravi tablets and Uptravi IV was well tolerated, and there were no unexpected safety findings.

The adverse reactions of Uptravi IV are similar to those of Uptravi tablets, except for infusion site reactions. Prostacyclin-related adverse reactions include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, limb pain, flushing, and joint pain.

 

The results of the study were published in the international medical journal “Respiratory Research” earlier this year, see: Temporarily switching from oral to intravenous selexipag in patients with pulmonary arterial hypertension: safety, tolerability, and pharmacokinetic results from an open-label, phase III study.

 

PAH: FDA approved Johnson & Johnson's Uptravi intravenous preparation

Selexipag chemical structure (picture source: Uptravi tablet instructions)

 

Kelly Chin, senior author of the aforementioned study at Uptravi IV, director of the Pulmonary Hypertension Program at the University of Texas Southwestern Medical Center and associate professor of internal medicine, said: “Given the progressive nature of this disease, maintenance therapy is very important to control PAH.

However, sometimes patients may not be able to control PAH. Taking oral medications. For patients taking Uptravi, bridging the short-term temporary interruption of Uptravi tablets with Uptravi IV can maintain the therapeutic effect and avoid the need to change treatment or retitrate Uptravi tablets after restarting treatment.”

 

Dr. Neil Davie, head of the global treatment area for pulmonary hypertension at Janssen Research and Development, said: “Today is an important day for patients who rely on Uptravi, because this new intravenous preparation meets the unmet needs of these patients.

As we are committed to As part of investing in research and understanding the science of Uptravi’s potential, we were inspired by this approval and proudly pave the way for advancing treatment options and care for patients with PAH.”

 

 

 

 

(source:internet, reference only)


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