Delayed US approval will hit Leo Pharma at full strength this year

Having first rejected eczema treatment tralokinumab, it took the US Food and Drug Administration eight additional months to approve the drug, a delay that had great consequences for developer Leo Pharma. Acting CEO Anders Kronborg says the FDA’s blow will begin to be felt for real this year.

Anders Kronborg, CFO and acting CEO at Leo Pharma until April | Photo: Martin Lehmann

by ULRICH QUISTGAARD, translated by daniel pedersen

Leo Pharma’s annual report published Thursday shows the repercussions from May of last year, when the US Food and Drug Administration decided not to grant the otherwise expected approval to atopic eczema drug tralokinumab.

Already a subscriber?Log in here

Read the whole article

Get access for 14 days for free. No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

With your free trial you get:

Access all locked articles

Receive our daily newsletters

Access our app

Get full access for you and your coworkers

Start a free company trial today

"Bad luck" delayed Leo Pharma's prize candidate for eight months
For subscribers
Leo Pharma's US sales organization waited 8 months on approval: "It has had an economic impact"
For subscribers
Leo Pharma disappoints as deficit surpasses USD 720m
For subscribers

Sign up for our newsletter

Stay ahead of development by receiving our newsletter on the latest sector knowledge.

Newsletter terms

Front page now

Former Demant Executive Vice President Arne Boye Nielsen was found responsible for creating an "unsafe psychological work environment" in an internal legal investigation. | Photo: Demant / Pr

Hearing health

Demant Foundation continues to work with ousted Demant executive

While the findings of a legal investigation were so serious that a Demant executive was fired, the majority owner of the hearing aid company subsequently elected him to several boards.

Sacked Demant executive receives USD 2.6 million golden handshake

Demant Board has "full confidence" in management's handling of unsafe work environment

For subscribers

Hearing health

CHMP recommends ten new medicines in June

For subscribers

Foto: George Frey/Reuters/Ritzau Scanpix

Pharma & biotech

Cosmetic Ozempic use under fire in EU amid drug shortages

Regulation

CHMP recommends conditional approval for Genmab and Abbvie's epcoritamab

For subscribers

Pharma & biotech

Pharmacosmos calls off the hunt for investors

For subscribers

Pharma & biotech

Novo to limit Wegovy’s China launch to avoid global disruption

Analyst on Novo Nordisk writedown: "It is a reminder of the risks"

On Wednesday, Novo Nordisk made a write-down of DKK 5.7bn (USD 817m) after a failed study.

Novo Nordisk snaps up partner's hemophilia candidate and gene editing technology

A five-year collaboration is coming to an end as Novo Nordisk has decided to acquire a drug candidate and gene technology from its former partner.

For subscribers

Bavarian Nordic expects Jynneos to be fully effective against new mpox variant

Bavarian Nordic’s vaccine Jynneos is the only approved vaccine against the disease mpox.

Novo Nordisk implements hiring freeze in certain departments

Since 2021, Novo Nordisk has increased its number of employees by 20,000 to total 66,000.

For subscribers

Foto: Medwatch/photo by Ulrich Quistgaard

Genmab cancer drug approved in new indication in US

Epkinly has become the first and only subcutaneously administered T-cell engaging bispecific antibody approved in the US for the treatment of this patient population.

Novo Nordisk blood pressure candidate ends in USD 817m flop

Novo Nordisk acquired ocedurenone from KBP Biosciences in 2023.

Novo Nordisk implements hiring freeze in certain departments

Since 2021, Novo Nordisk has increased its number of employees by 20,000 to total 66,000.

For subscribers

Hearing health

Demant Foundation continues to work with ousted Demant executive

While the findings of a legal investigation were so serious that a Demant executive was fired, the majority owner of the hearing aid company subsequently elected him to several boards.

For subscribers

Pharma & biotech

Cosmetic Ozempic use under fire in EU amid drug shortages

The success of Novo Nordisk’s Ozempic and Wegovy as well as blockbuster shots made by rival Eli Lilly has left some patients with diabetes struggling to continue their treatment.

Pharma & biotech