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

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Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9:45 p.m. ET: 19,282,972 — Total deaths: 718,851 — Total recoveries — 11,671,491Map.
  2. U.S.: Total confirmed cases as of 9:45 p.m. ET: 4,937,441 — Total deaths: 161,248 — Total recoveries: 1,623,870 — Total tests: 60,415,558Map.
  3. Politics: Trump says he's prepared to sign executive orders on coronavirus aid.
  4. Education: Cuomo says all New York schools can reopen for in-person learning.
  5. Public health: Surgeon general urges flu shots to prevent "double whammy" with coronavirus — Massachusetts pauses reopening after uptick in coronavirus cases.
  6. World: Africa records over 1 million coronavirus cases — Gates Foundation puts $150 million behind coronavirus vaccine production.

Warren and Clinton to speak on same night of Democratic convention

(Photos: Abdulhamid Hosbas/Anadolu Agency via Getty Images, Sean Rayford/Getty Images)

Sen. Elizabeth Warren and Hillary Clinton both are slated to speak on the Wednesday of the Democratic convention — Aug. 19 — four sources familiar with the planning told Axios.

Why it matters: That's the same night Joe Biden's running mate (to be revealed next week) will address the nation. Clinton and Warren represent two of the most influential wise-women of Democratic politics with the potential to turn out millions of establishment and progressive voters in November.

Trump considering order on pre-existing condition protections, which already exist

Photo: Jim Watson/AFP via Getty Images

President Trump announced on Friday he will pursue an executive order requiring insurance companies to cover pre-existing conditions, something that is already law.

Why it matters: The Affordable Care Act already requires insurers to cover pre-existing conditions. The Trump administration is currently arguing in a case before the Supreme Court to strike down that very law — including its pre-existing condition protections.