Lundbeck shares slip after FDA rebuff

Shares in Danish CNS specialist Lundbeck (LUND: CO) have fallen 4% on the news that the company, together with development partner Takeda Pharmaceutical (TYO: 4502), has not succeeded in adding new data to the label for depression therapy Trintellix (vortioxetine).

The companies had applied to the US Food and Drug Administration to include new data in the clinical trials section of the prescribing information for the drug, which is approved in the USA for treating aspects of cognitive dysfunction in adults with major depressive disorder (MDD).

The drug, which was discovered by Lundbeck, was developed jointly by Lundbeck and Japanese drugmaker Takeda, which holds the licence for the US market.

The companies said in a press release: “Takeda and Lundbeck are disappointed, but we believe in the strength of the data and plan to continue discussions with the FDA on potential paths forward.”

“We remain committed to the depression community and Trintellix as a treatment option for adult patients living with depression, including those who suffer from cognitive dysfunction as part of this disease.”

The most commonly observed adverse events in MDD patients treated with Trintellix in 6-8 week placebo-controlled studies (incidence greater than or equal to 5% and at least twice the rate of placebo) were nausea, constipation and vomiting.

Overall, 5% to 8% of the patients who received Trintellix 5 to 20 mg/day in short-term trials discontinued treatment due to an adverse reaction, the most common being nausea, compared with 4% of placebo-treated patients in these studies.