FDA issues complete response letter to Leo Pharma's tralokinumab

Leo Pharma's plans to soon launch dermatitis drug tralokinumab in the US were halted on Thursday, since the FDA has rejected the firm's application for marketing authorization and asks for more data on the injection pen that the drug is packaged in.

Photo: Leo Pharma / PR

Less than a week after the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) approved Leo Pharma's drug tralokinumab, the US Food and Drug Administration (FDA) has arrived at the opposite conclusion in the form of a complete response letter.

In the letter, the FDA calls for further data concerning the device component of tralokinumab that is the injection pen which holds the drug, according to a Leo Pharma press release.

Read the whole article

Get 14 days free access.

No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
An error has occured. Please try again later.

Get full access for you and your coworkers.

Start a free company trial today

More from MedWatch

Coloplast upgrades growth expectations following acquisition

Medtech firm Coloplast’s Q1 report for 2021/2022 brings a slight upward adjustment of the reported revenue growth outlook due to foreign exchange developments. Coloplast’s acquisition of Atos Medical is expected to contribute around 6 percent to organic growth.

Demant's surgical division loses president of 13 years

Oticon Medical, the implants division at hearing group Demant, is saying goodbye to President Jes Olsen, who is exiting his role in March after having spearheaded the business leg since 2008. Demant CEO Søren Nielsen is stepping in temporarily until a replacement is found.

Hearing aid market in US grew by 37 percent in 2021

Hearing aid manufacturers have had a good year following one of the worst in their recorded history, as sales in the US have gone up by 37 percent. The progress is mainly driven by the recovery of independent retailers, whereas public sales channel Veterans Affairs still lags behind.

Further reading

Related articles

Latest news

See all jobs