Boehringer Ingelheim fibromyalgia given negative opinion by CHMP

Boehringer Ingelheim has announced that its fibromyalgia treatment Cymbalta (duloxetine hydrochloride) has received negative opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The product was developed and commercialised as a joint project between Boehringer Ingelheim and fellow pharmaceutical company Eli Lilly.

Duloxetine has already been approved throughout various parts of Europe as a treatment for major depressive episodes, stress urinary incontinence and generalised anxiety disorder as well as diabetic peripheral neuropathic pain.

However, no medication has been approved on the continent for fibromyalgia, Boehringer Ingelheim added. Fibromyalgia is often described as widespread and chronic pain throughout the body.

Dr James Russell, Eli Lilly’s global medical director for duloxetine, said both companies were “disappointed” by the CHMP’s decision.

“We remain confident in the duloxetine data,” he commented.

Meanwhile, Boehringer Ingelheim announced earlier this month it had signed an agreement to obtain worldwide exclusive commercialisation and development rights for one of Evec’s fully-human therapeutic antibody programmes.

In return, Japan-based Evec is to receive payments totalling up to 55 million euros (44.37 million pounds).