(Reuters) – Price Vertex Pharmaceuticals Inc. is combined by cystic fibrosis drugs (CF) at $ 311,503 per year, after its early approval on Monday.
FILE FILE: The view of the US Food and Drug Administration (FDA) headquarters shows in Silver Spring, Maryland 14 August, 2012. REUTERS / Jason Reed / File Photo
The drug maker's shares, which also raised its 2019 sales forecast for CF products, were up 3% in post-time trade.
The Food and Drug Administration approval, which comes five months before the agency's previously announced date of action, makes a large increase in the percentage of cystic fibrosis patients who can treat Vertex.
The drug maker contributed its range of guidance for sales of CF products between $ 3.70 billion and $ 3.75 billion, from $ 3.60 billion to $ 3.70 billion.
Trikafta is a mixture of three drugs that focus on defective protein that is responsible for the life-threatening disease and creates thick mucus accumulation in body parts such as the lungs and digestive tract. (bit.ly/2MxqCrJ)
Trikafta is the first approved treatment that is effective for patients aged 12 years and over, with a genetic mutation that affects 90% of CF patients or about 27,000 people in the United States, said the t agency.
The drugs are closed in Trikafta than ivacaftor and tezacaftor, who make up the drug approval Symdeko CF Vexex previously. Ivacaftor is sold as an independent treatment, Kalydeco, and is part of another double CF combination product called Orkambi.
The Trikafta function improved 14% of the lung function in clinical trials, compared to an improvement of about 3% on patients dealt with Orkambi.
A price list is about $ 272,000 per year at Orkambi, and listed about $ 292,000 in Symdeko.
The analysts are looking forward to the early approval to accelerate the launch date for Trikafta, which they expect to reach $ 630 million in 2020.
However, the approval comes at a time when the drug makers were getting back from healthcare payers for the price of its current CF therapies.
A health care system run by the government in England is going to agree on Orkambi Vertex to pay on the basis that Vertex requires the price from the country is too high. The rebates offered by Vertex were not publicly disclosed in the negotiations.
CF is a chronic, progressive and fatal genetic disease, mainly affecting the respiratory and digestive systems in children and young adults.
Reporting by Carl O Donnell in New York and Manojna Maddipatla in Europe Europe; Edited by Shailesh Kuber
. Healthcare Issues (TRBC) (t) Biotechnology and Medical Research (TRBC) (t) USA