Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix

Lundbeck India Private Limited (LIPL) announces the launch of Brintellix (vortioxetine) in India for the treatment of patients suffering from major depressive disorder (MDD) after receiving approval from Drug Controller General of India (DCGI).

About Brintellix:

Brintellix is a novel multimodal antidepressant which has been specifically designed to inhibit serotonin reuptake and modulate serotonergic receptor activity of the neurons in the brain of affected patients. It has demonstrated significant efficacy in reducing the mood symptoms in adult patients with depression as measured by traditional scales like MADRS or HAMD.

It has also demonstrated improvement of cognitive performance in adult patients with depression, as measured with neuropsychological tests. Cognitive symptoms are part of the diagnostic criteria for depression, and include the ability to concentrate, make decisions and the ability to remember. Cognitive symptoms are both part of the acute depressive episode as well as often being a residual symptom of depression. This means that patients with depression may have difficulties performing their duties at work which leads loss of productivity and it impacts the person, his family and the society.

Clinical Study and Outcome:

As per a large-scale survey conducted by NIMHANS, an estimated 1 in 20 people in India suffers from depression. Mental disorders such as major depressive disorder or depression affects everyone, irrespective of age, gender and living standards but research has shown that some segments of population seem to be at a higher risk of suffering from depression especially women and urban dwellers. There could be several factors like fast paced lifestyle, stress, complexities of living, breakdown of support systems, challenges of economic instability for this higher prevalence in urban population.

Development to commercialization of Vortioxetine:

• Vortioxetine was discovered by scientists at Lundbeck who reported the rationale and synthesis for the drug (then called Lu AA21004) in a 2011 paper.
• In 2007, the compound was in Phase II clinical trials, and Lundbeck and Takeda entered into a partnership in which Takeda paid Lundbeck $40 million upfront, with promises of up to $345 million in milestone payments, and Takeda agreed to pay most of the remaining cost of developing the drug. The companies agreed to co-promote the drug in the US and Japan, and that Lundbeck would receive a royalty on all such sales. The deal included another drug candidate, tedatioxetine (Lu AA24530), and could be expanded to include two other Lundbeck compounds.
• Vortioxetine was approved by the U.S. FDA for the treatment of major depressive disorder (MDD) in adults in September 2013, and it was approved in Europe later that year.
• Vortioxetine was previously trademarked as Brintellix in the United States, but on May 2, 2016, the US FDA approved a name change to Trintellix in order to avoid confusion with the blood-thinning medication Brilinta
• In 2018, Vortioxetine is approved by DCGI, India. The brand name for Vortioxetine of Lundbeck in Indian market is Brintellix.