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Mucoviscidosis (accumulation of mucus in the respiratory tract), seen on a frontal X-ray of the chest. Photo: BSIP/Universal Images Group via Getty Images

The Food and Drug Administration has approved a triple combination therapy manufactured by Vertex that would treat 90% of patients with cystic fibrosis.

The big picture: The approval of Trikafta came in record time at five months and will be priced at $311,503 annually, or $23,896 per 28-day pack, according to the Securities and Exchange Commission.

  • Cystic fibrosis is a chronic, progressive and frequently fatal genetic disease that primarily affects the respiratory and digestive systems of children and young adults.
  • Patients over the age of 12 with at least one F508del mutation of the inherited disease will be eligible for the therapy. In clinical trials, patients who received Trikafta experienced significant improvements in lung function, STAT News reports.
  • Vertex shares jumped more than 4% on the news.

What they're saying:

“In the past few years, we have seen remarkable breakthroughs in therapies to treat cystic fibrosis and improve patients’ quality of life, yet many subgroups of cystic fibrosis patients did not have approved treatment options. That’s why we used all available programs ... to help advance today’s approval in the most efficient manner possible, while also adhering to our high standards."
— Acting FDA commissioner Ned Sharpless

Go deeper

2 hours ago - Health

Biden says it's "not the time to relax" after touring vaccination site

President Biden speaking after visiting a FEMA Covid-19 vaccination facility in Houston on Feb. 26. Photo: Mandel Ngan/AFP via Getty Images

President Biden said Friday that "it's not the time to relax" coronavirus mitigation efforts and warned that the number of cases and hospitalizations could rise again as new variants of the virus emerge.

Why it matters: Biden, who made the remarks after touring a vaccination site in Houston, echoed CDC director Rochelle Walensky, who said earlier on Friday that while the U.S. has seen a recent drop in cases and hospitalizations, "these declines follow the highest peak we have experienced in the pandemic."

Updated 2 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Annelise Capossela/Axios

  1. Health: Most COVID-19 survivors can weather risk of reinfection, study says — "Twindemic" averted as flu reports plummet amid coronavirus crisis
  2. Vaccine: FDA advisory panel endorses J&J COVID vaccine for emergency use — About 20% of U.S. adults have received first vaccine dose, White House says — New data reignites the debate over coronavirus vaccine strategy.
  3. Economy: What's really going on with the labor market.
  4. Local: All adult Minnesotans will likely be eligible for COVID-19 vaccine by summer — Another wealthy Florida community receives special access to COVID-19 vaccine.
  5. Sports: Poll weighs impact of athlete vaccination.

The week markets went wild

Illustration: Lazaro Gamio

The markets just closed out a manic week.

Why it matters: Outsized — and in some cases historic — moves were evident across the board.