FDA has approved Ofev, first treatment for patients with interstitial lung disease associated with systemic sclerosis or scleroderma


The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD.
It is the first FDA-approved treatment for this rare lung condition.

Scleroderma is a rare disease that causes tissue throughout the body, including the lungs and other organs, to thicken and scar.
Interstitial lung disease or ILD is a condition affecting the interstitium, which is part of the lung’s structure, and is one of the most common disease manifestations of scleroderma.
SSc-ILD is a progressive lung disease in which lung function declines over time, and it can be debilitating and life-threatening.
Interstitial lung disease is the leading cause of death among people with scleroderma, typically resulting from a loss of pulmonary function that occurs when the lungs cannot supply enough oxygen to the heart.
Approximately 100,000 individuals in the United States have scleroderma, and approximately half of scleroderma patients have SSc-ILD.

The effectiveness of Ofev to treat SSc-ILD was studied in a randomized, double-blind, placebo-controlled trial of 576 patients ages 20-79 with the disease.
Patients received treatment for 52 weeks, with some patients treated up to 100 weeks.
The primary test for efficacy measured the forced vital capacity, or FVC, which is a measure of lung function, defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Those who took Ofev had less lung function decline compared to those on placebo.

The overall safety profile observed in the Ofev treatment group was consistent with the known safety profile of the therapy.
The most frequent serious adverse event reported in patients treated with Ofev was pneumonia ( 2.8% Ofev versus 0.3% placebo ).
Adverse reactions leading to permanent dose reductions were reported in 34% of Ofev-treated patients compared to 4% of placebo-treated patients.
Diarrhea was the most frequent adverse reaction that led to permanent dose reduction in patients treated with Ofev.

The prescribing information for Ofev includes warnings for patients with moderate or severe hepatic impairment, those with elevated liver enzymes and drug-induced liver injury and patients with gastrointestinal disorders.
Ofev may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events, bleeding and gastrointestinal perforation.

P-gp and CYP3A4 inhibitors may increase Nintedanib exposure, and patients taking these inhibitors should be closely monitored for tolerability of Ofev.
Common side effects noted with Ofev include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss and hypertension.

Ofev was originally approved in 2014 for adult patients with idiopathic pulmonary fibrosis ( IPF ), which is another interstitial lung condition. ( Xagena )

Source: FDA, 2019

XagenaMedicine_2019



Indietro

Altri articoli

The FDA ( U.S. Food and Drug Administration ) has approved Rinvoq ( Upadacitinib ), a 15 mg, once-daily oral...


The FDA ( Food and Drug Administration ) has approved Inrebic ( Fedratinib ) for adults with intermediate-2 or high-risk...


Detailed results from the landmark phase III DAPA-HF trial, presented at the ESC Congress 2019, have shown that Dapagliflozin (...


The European Commission ( EC ) has approved Empliciti ( Elotuzumab ) plus Pomalidomide and low-dose Dexamethasone ( EPd )...


Results from a phase 1 study evaluating the pharmacokinetics and safety of a prototype subdermal drug-eluting implant for extended administration...


Edoxaban ( Lixiana ) in combination with a P2Y12 inhibitor is noninferior to standard triple therapy for preventing bleeding in...


The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen...


Sodium glucose co-transporter 2 ( SGLT2 ) inhibitors reduce serum urate levels. In a post hoc analysis researchers have investigated...


The phase III MONALEESA-3 trial investigated Ribociclib, a cyclin-dependent kinase 4/6 ( CDK4/6 ) inhibitor, plus Fulvestrant as first-line...