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”
The PVRMS19 was presented at the Omni Shoreham Hotel, Washington DC, January 2019. During the packed three-day event, we learned that many aspect governing the development and subsequent safe and effective use of medicines are in a state of flux… and so they should be. As we learn by our actions (triumphs and failures) we make adjustments to enhance the future investigations and create medicinal agents that are effective and safe, or more precisely, have a benefit that outweighs the risks. Continue reading “Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)”
New study shows how drug manufacturers can reduce wastage, and therefore their costs, by altering the size of the vials they produce
Heidelberg | New York, 5 December 2018
Pharmaceuticals are often dosed according to patient weight or body size which means that a dose must be individually measured. In a new study, lead author Anthony Hatswell of Delta Hat Limited and University College London in the UK, shows that by optimizing drug dose sizes available, wastage can be cut by as much as 50 per cent. The research is in the Adis journal Applied Health Economics and Health Policy, which is published by Springer Nature.
Many pharmaceuticals, such as drugs used for cancer treatment, are only available in standard quantities, for example in 100 milligram packages. In this study, Hatswell and his co-author Joshua Porter investigated how the quantity of medicine in each package could be varied to reduce the overall wastage. This would allow manufacturers to cut their costs, helping to make medicines available to patients.
To calculate the level of wastage, the authors looked at statistics from the Health Survey for England, which gives data on the height and weight of over 5000 individuals. Using this data they calculated how much drug would be wasted at every combination of vial sizes. The analysis was then tailored to the characteristics of patients with the disease (for example, males are heavier and taller than females on average), before the total wastage was aggregated over the population. By looking at all possible combinations of package sizes, Hatswell and Porter were then able to find those with low levels of wastage. The steps laid out in the publication can therefore be applied to any drug that does not have a fixed dose.
The researchers found that wastage from the cancer drug pembrolizumab (Keytruda®, Merck, which is on track for sales of more than $5 billion in 2018) could be cut from 13.3 per cent to 8.7 per cent. Similarly the prostate cancer drug cabazitaxel (Jevtana®, Sanofi) could see wastage cut from a projected 19.4 per cent to 6.5 per cent.
“We use methods such as integer programming and operations research which date back to the Second World War and are widely used in the manufacturing of consumer goods. Their application to healthcare represents a novel step which ultimately we hope will help patients access important new medicines,” explains Hatswell.
Reference: Hatswell & Porter (2018). Reducing drug wastage in pharmaceuticals dosed by weight or body surface areas by optimising vial sizes, Applied Health Economics and Health Policy DOI: 10.1007/s40258-018-0444-0
Springer Nature sponsored the annual meeting of the International Society of Pharmacovigilance (ISoP) Middle East Chapter under the Adis Pharmacovigilance brand, held on the 20th of September 2018 in Dubai. ISoP is an international non-profit organisation which aims to promote pharmacovigilance and enhance the safety and proper use of drugs worldwide. Continue reading “Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting”
Adis Pharmacovigilance attended the World Drug Safety Congress in Amsterdam on Sept 10th and 11th.
The event has been running for over a decade and is world renowned for its ability to connect key stakeholders in the drug safety field, as well as for leading the way in moving the sector forward.
Senior level drug safety professionals, as well as representatives from sponsors and service providers, met to discuss key topics and showcase solutions.
This year’s theme, Addressing Key Challenges for Safety Professionals, had us prepared for a series of interesting presentations and discussions on the ever growing importance of pharmacovigilance and the challenges connected with ensuring patient safety. Continue reading “The World Drug Safety Congress in Amsterdam addresses key challenges”
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”