Page 33 - ASPRI2223 eDirectory

DIRECTORY OF SINGAPORE PROCESS & CHEMICALS INDUSTRIES 2022/2023
New FDA drug approvals
Fifty novel drugs received the US Food and Drug Administration (FDA) approval in 2021, in line with recent trends, despite the continued impact of Covid-19. Among them were AbbVie’s Qulipta for episodic migraine, Leo Pharma’s ADBRY for moderate to severe eczema, and Biogen’s costly Aduhelm, the first Alzheimer’s drug for cognitive decline, which debuted at a princely cost of US$56,000 a year.
Twenty-six of the drugs approved were for rare or orphan diseases defined as diseases that affect less than 200,000 people in the US. Among them was Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The
excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.
FDA’s Center for Drug Evaluation and Research (CDER) also took steps to advance treatment options for patients with diabetes by approving several diabetes medications, including one interchangeable biosimilar insulin product and one biosimilar insulin product, which can provide patients with additional safe, high-quality, and potentially more cost-effective options. CDER also approved a treatment for paediatric patients ages 10 and older with type 2 diabetes and a therapy for severe hypoglycemia, or low blood sugar, in patients aged six years and older with diabetes.
Yet, some applications did face pandemic challenges. In November 2021, FDA reported that 55 new drug applications encountered inspection delays.
Record high
for drug innovation
Drug innovation is setting new records in the level of investment, activity and scientific progress, in addition to the number and range of new medicines reaching patients in spite of the many operational and organisational challenges presented by Covid-19, said the IQVIA in its latest report, Global Trends in R&D: Overview through 2021.
In terms of new drug approvals and launches, 84 novel active substances (NASs) were launched globally in 2021, double the number five years ago, bringing the total over the past 20 years to 883. The US headed the field with 72 NASs launched in 2021, of which 44 were characterised by the FDA as first-in- class, and more than half carried an orphan drug designation.
R&D reached new levels. Over 6,000 products are on human trials globally, up 68% over 2016, as companies continued to invest and advance innovative therapeutics and vaccines across a wide range of disease areas. In oncology, targeted therapies account for almost all of the research, and over 40% of the pipeline was for rare cancers.
Overall clinical trial activity was sustained through the pandemic, IQVIA noted, as the industry adapted to the disruption and developed new approaches to enable research to continue. In 2021, 5,500 new planned clinical trial starts were reported, up 14% over 2020 and 19% higher than 2019.
Over 2 million study participants were involved in new trials for the first time in 2021, double the level seen prior to the trials for both Covid-19 and several very large Ebola virus vaccine trials.
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