The FDA on Friday approved Zolgensma, a gene replacement therapy from Novartis that treats spinal muscular atrophy, for use in children younger than 2.

Why it matters: The treatment attacks a debilitating genetic disease that often kills infants, and it will come with a price tag of more than $2.1 million, making Zolgensma the most expensive drug on the planet.

Details: Novartis said it will allow health insurance companies to pay the $2.1 million, which does not factor in potential rebates or discounts, over 5 years.

  • That puts Zolgensma's annual list price at $425,000, which Novartis said is less expensive than Spinraza, a competing therapy for spinal muscular atrophy made by Biogen.

Between the lines: The Institute for Clinical and Economic Review, a group that evaluates drug pricing and effectiveness, said in a statement that an appropriate all-in price range for Zolgensma would be between $1.1 million and $1.9 million — below what Novartis set.

  • Other ICER estimates say the price should be even lower, between $310,000 and $900,000.
  • Novartis acquired AveXis, the biotech firm that developed this gene therapy, for $8.7 billion last year, so investors want a return for that investment.

The bottom line: Zolgensma is emblematic of the new scientific advances that treat people with crippling diseases and of the debate society will have over how it should pay for these types of therapies.

Go deeper: The drug pricing debate is stuck in the past

Go deeper

Two officers shot in Louisville amid Breonna Taylor protests

Police officers stand guard during a protest in Louisville, Kentucky. Photo: Ben Hendren/Anadolu Agency via Getty Images

Louisville Metro Police Department said two officers were shot downtown in the Kentucky city late Wednesday, just hours after a grand jury announced an indictment in the Breonna Taylor case.

Driving the news: Metrosafe, the city's emergency services, said it received reports of a shooting at South Brook St. and Broadway Ave., near the area where protests were taking place. A police spokesperson told a press briefing the injuries of both officers were not life-threatening. One officer was "alert and stable" and the other was undergoing surgery, he said.

Updated 1 hour ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9 p.m. ET: 31,778,331 — Total deaths: 974,436 — Total recoveries: 21,876,025Map.
  2. U.S.: Total confirmed cases as of 9 p.m. ET: 6,943,078 — Total deaths: 201,930 — Total recoveries: 2,670,256 — Total tests: 97,459,742Map.
  3. Health: CDC director says over 90% of Americans have not yet been exposed to coronavirus — Supply shortages continue to plague testing.
  4. Politics: Missouri Gov. Mike Parson tests positive for coronavirus — Poll says 51% of Republicans trust Trump on coronavirus more than the CDC.
  5. Technology: The tech solutions of 2020 may be sapping our resolve to beat the coronavirus
  6. Vaccines: Johnson & Johnson begins large phase 3 trial — The FDA plans to toughen standards.
  7. Sports: Less travel is causing the NBA to see better basketball.
  8. Future: America's halfway coronavirus response

Biden: Breonna Taylor indictment "does not answer" call for justice

Former Vice President Joe Biden. Photo: Leigh Vogel/Getty Images

Former Vice President Joe Biden on Wednesday condemned the grand jury indictment of a Louisville police officer who entered Breonna Taylor's home in March in a botched drug raid that led to her death, saying in a statement the decision "does not answer" for equal justice.

The big picture: Biden called for reforms to address police use of force and no-knock warrants, while demanding a ban on chokeholds. He added that people "have a right to peacefully protest, but violence is never acceptable."

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