Pharmaceutical group AstraZeneca (LSE: AZN) announced further progress for its Major Depressive Disorder (MDD) treatment pipeline. The US Food and Drug Administration (FDA) approved the once-daily SEROQUEL XR Tablets as an add-on to supplement antidepressant treatments in adults.
SEROQUEL XR is part of a class of drugs called atypical antipsychotics and is approved for a number of mental health disorders. The drug is currently approved for the acute and maintenance treatment of bipolar disorder and schizophrenia.
Major Depressive affects approximately 42 million people worldwide, AstraZeneca said, adding that the global antidepressant market is valued at over US$20 billion per annum. Serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed class of drugs for depression, however according to some studies many patients fail to respond adequately. The NIMH STAR*D study suggests that approximately 63% of patients do not achieve remission with first-line SSRI treatment.
The FTSE100 drug maker said the approval provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant. SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, the group said.
AstraZeneca also received a Complete Response Letter (CRL) from the FDA asking for additional information for the supplemental new drug applications (sNDA) for SEROQUEL XR as acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients.
This latest FDA approval for the pharmaceutical major follows yesterday’s news of a new licensing and collaboration deal in respect of another MDD adjunct treatment. AstraZeneca tied up the deal for Targacept Inc’s (NASDAQ: TRGT) TC-5214 treatment.
Targacept’s TC-5214, is being developed as an additional supplement to antidepressant therapy in adults with MDD who do not respond adequately to first-line antidepressant treatment. TC-5214 is a nicotinic channel blocker, which recently completed a Phase IIb clinical trial. It is thought to treat depression by modulating the activity of various neuronal nicotinic receptor (NNR) subtypes.
AstraZeneca and Targacept will jointly design a global Phase III clinical programme which is expected to begin in mid-2010. The collaboration has targeted 2012 to file a new drug application with the US Food and Drug Administration.
AstraZeneca will be responsible for 80% of the development costs and will be responsible for the commercialisation of TC-5214. The pharmaceutical giant will also assume Targacept's manufacturing and supply agreements with third parties in relation to TC-5214.
The two companies will also negotiate a potential multi-year research programme, which may see Targacept develop additional NNR Therapeutics for MDD and possibly other indications.