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 Shares of the drugmaker, which also raised its 2019 sales forecast
for CF products, were up 3% in after-hours trading.
The U.S. Food and Drug Administration approval, which comes five
months ahead of the agency's previously announced action date,
greatly expands the percentage of cystic fibrosis patients that
Vertex can treat.
The drugmaker boosted its guidance range for CF products sales to
between $3.70 billion and $3.75 billion, from $3.60 billion to $3.70
billion.
The treatment, Trikafta, is a combination of three drugs that target
a defective protein responsible for the life-threatening disease
that causes the build up of thick mucus in body parts such as the
lungs and digestive tract. (https://bit.ly/2MxqCrJ)
Trikafta is the first approved treatment that is effective for
patients 12 years and older, who have a genetic mutation which
affects 90% of CF patients or roughly 27,000 people in the United
States, the agency said.
The backbone drugs in Trikafta are ivacaftor and tezacaftor, which
make up Vertex's previously approved CF drug Symdeko. Ivacaftor is
also sold as a standalone treatment, Kalydeco, and is part of
another double combination CF product called Orkambi.
Trikafta improved lung function by around 14% in clinical trials,
compared with a roughly 3% improvement in patients treated with
Orkambi.
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Orkambi has a list price of around $272,000 per year, while Symdeko
lists at around $292,000.
Analysts expect the early approval to accelerate the launch date for
Trikafta, which they expect will make $630 million in 2020.
However, the approval comes at a time when the drugmaker has been
receiving push back from healthcare payers for the price of its
existing CF therapies.
England's government-run healthcare system has been holding out on
agreeing to pay for Vertex's Orkambi on the grounds that the price
that Vertex is demanding from the country is too high. The rebates
that Vertex offered in the negotiations have not been publicly
disclosed.
CF is a chronic, progressive, and frequently fatal genetic disease,
primarily affecting the respiratory and digestive systems in
children and young adults.
(Reporting by Carl O'Donnell in New York and Manojna Maddipatla in
Bengaluru; Editing by Shailesh Kuber)
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