In March 2019, the small molecule brexanolone was approved by the United States Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adult women. Brexanolone, developed by Sage Therapeutics under a license from the University of California, was granted priority review status and breakthrough therapy designation by the FDA. Continue reading “Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression”
It is likely that in one’s lifetime a friend or family member will be diagnosed with Alzheimer’s disease. As of 2018, approximately 50 million people worldwide are living with dementia and this number is expected to triple to 152 million by 2050.
Despite the increasing prevalence of the disease, no new drugs have been approved for the treatment of Alzheimer’s since 2003. An article recently published on PharmaTimes proclaims, “The search for a cure for Alzheimer’s is far from over.”
In December 2018, roxadustat, developed by FibroGen, in collaboration with Astellas and AstraZeneca, received its first global approval in China for the treatment of anaemia in patients with dialysis-dependent chronic kidney disease (DD-CKD). Roxadustat is expected to launch in China in the second half of 2019.
The recent first global approval of tagraxofusp (Elzonris™) has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In December 2018, tagraxofusp, developed by Stemline Therapeutics, was approved by the United States Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children 2 years and older. Continue reading “Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy”
Avatrombopag (Doptelet ®) received its first global approval in the US; this was reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease”
Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”
In July 2018 durvalumab (Imfinzi ®) received a positive opinion from the Committee for Medical Products for Human Use (CHMP). The committee recommended marketing authorisation for the agent in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells, and whose disease has not progressed following platinum-based chemotherapy and radiation therapy.  Continue reading “Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe”
In July 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) recommended not to reimburse dupilumab. Continue reading “Dupilumab (Dupixent®): CADTH Publishes Negative Recommendation for Reimbursement in Canada”
Durvalumab (IMFINZI®) was approved by the Japanese Ministry of Health, Labour and Welfare in July 2018, for maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC). Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan”
In September 2017, the US FDA made public a draft industry guideline entitled “Statistical Approaches to Evaluate Analytical Similarity.” Its aim was to provide advice, to sponsors developing biosimilar agents, on how to demonstrate that the product under investigation is “highly similar” to the referenced biological. After taking into consideration the public comments relating to the document, the FDA withdrew the guideline in June 2018 for further evaluation and development to ensure that the scientific and regulatory issues that had been raised would be appropriately addressed. Continue reading “FDA to revisit guidelines for biosimilar development pathway”