Janssen, Lundbeck and Takeda Raise Issues With FDA Draft Guidance on MDD Drugs
Three drugmakers have raised questions with the US Food and Drug Administration’s (FDA) draft guidance on developing major depressive disorder (MDD) treatments.Lundbeck used its comments to urge FDA to refrain from classifying antidepressants based on the timing of their onset of effect. Instead, Lundbeck said it believes that this attribute is best reflected in prescription drug labeling claims.
Similarly, Janssen said it disagrees with the categorical distinction between partial responders and nonresponders (TRD) and the proposed requirement to study TRD in only monotherapy studies.
“Respectfully, we would like the Agency to consider an alternative approach, in which the study design and study populations are based on the pharmacological properties of the study drug and relevant clinical data,” Janssen said.
And although this draft guidance focuses on MDD, Janssen noted that some of the principles described may be applicable to clinical trials of drugs intended to treat other forms of depression.
“Recognizing recruitment challenges and high unmet need for safe and more effective treatments for pediatric and adolescent patients with major depression, Janssen requests the Agency to consider innovative approaches and flexibility in the required number of adequate and well-controlled short-term clinical studies in these patient populations,” the drugmaker said.
Takeda, meanwhile, recommended that the draft address “development strategies for an antidepressant to demonstrate an effect on specific symptoms (e.g. cognitive dysfunction, anhedonia) or reduced liability of common adverse events (e.g. treatment-emergent sexual dysfunction, somnolence/insomnia, discontinuation symptoms).”
Takeda, like Janssen, sought flexibility in designing trials for patients with TRD. Takeda also sought specific guidance on which types of digital health technologies can be used to collect real world data.
Comments