US FDA approves Johnson & Johnson's drug for immune-mediated disorder

Health care giantJohnson & Johnson said on Wednesday the US Food and Drug Administration (FDA) has approved its drug to treat patients aged 12 years and older with an immune-mediated disorder.

The drug was approved for patients with a form of generalized myasthenia gravis (gMG) - an immunity-related disorder that weakens the skeletal muscles, especially those in the eyes, mouth, throat and limbs. It will be sold under the brand name Imaavy.

The regulatory approval was based on a 24-week late-stage study where Imaavy helped patients to perform essential daily functions such as chewing, speaking and breathing.

The medicine works by blocking a receptor called FcRn, and helps reduce overall levels of IgG, a type of antibody responsible for gMG.

The drugmaker also said the drug approval covers more than 90% of the patient population.

According to the government data, the generalized myasthenia gravis disorder affects about 10 to 20 individuals per 100,000 in the US.

Imaavy will compete with rival treatments such as those by Argenx SE, AstraZeneca and UCB.

Johnson & Johnson, which expects peak sales of more than $5 billion from the drug, acquired it through a $6.5 billion buyout of autoimmune disease specialist Momenta in 2020.

J&J expects $400 million in tariff-related costs

Earlier in April, the health care giant said it expects about $400 million in tariff-related costs this year.

The costs will be felt primarily within the company's medical technology unit, which makes a range of medical devices and surgical products. The most substantial impact comes from tariffs against China and retaliatory tariffs from China, said Joseph Wolk, Johnson & Johnson's chief financial officer.

The cost estimate does not include possible tariffs on imports of pharmaceuticals.

The company also said it is investing more than $55 billion over the next four years with the goal of making all of its advanced medicines that are used in the US.