By Joseph W. Polli, Ph.D., FAAPS, President
In 2019, the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 48 novel drugs, which is the third most approved drugs per year in 25 years. Glancing through the list, I notice a handful of monoclonal antibodies, some autoimmune treatments, and many cancer therapies. All these new drug approvals are important for treating, preventing, and curing diseases globally. AAPS members and partners helped make this happen.
I highly recommend reading this month’s special feature article, Drugs Studied by AAPS Members Received FDA Approval in 2019. While we could only pinpoint and receive permission from members who worked on a handful of the approved drugs, you all contributed to the body of science that led to these therapies.
AAPS members have published on topics covering the breadth of pharmaceutical sciences—from ophthalmic drug development to nano-delivery systems for cancer treatments to innovations in material selection. That research adds to the scientific knowledge bank affecting the development of new therapies. Likewise, presenting and attending sessions and posters at PharmSci 360 and other AAPS workshops, like the current COVID-19 Workshop and submitting your abstract for PharmSci 360 by May 6, helps members delve deep into new research to enhance their own knowledge.
Many of our sustaining sponsors, who support AAPS programs and events year-round, were integral in 2019 drug approvals as well.
Sanofi, with Ablynx, sponsored the drug caplacizumab to treat acquired thrombotic thrombocytopenic purpura. Abbvie sponsored risankizumab, which is an injection to help with plaque psoriasis. AstraZeneca, along with Daiichi Sankyo, developed a treatment for HER2-positive breast cancer called trastuzumab deruxtecan. Roche sponsored two 2019 approvals: polatuzumab vedotin for diffuse large B-cell lymphoma and entrectinib for NTRK fusion- positive solid tumours and ROS1-positive NSCLC. Merck and Co. developed a combination product of imipenem, cilastatin, and relebactam to treat complicated urinary tract and complicated intra-abdominal infections. And Pfizer worked with Foldrx on tafamidis for heart disease caused by transthyretin mediated amyloidosis (ATTR-CM)—the first FDA-approved treatments for ATTR-CM—and with Mylan for pretomanid, a new treatment for tuberculosis.
Separately, the FDA Center for Biologics Evaluation and Research approves biological products like vaccines and gene therapies. Merck and Co. received approval for the first vaccine for Ebola prevention in 2019, and Sanofi Pasteur received approval for Dengvaxia for the prevention of dengue disease.
AAPS offers many resources to learn more about research advancements, to collaborate, and even to find a new job. AAPS members are hugely valuable to the future health of our society, and AAPS wants to help.
The Board of Directors extends our thanks to all AAPS members for their dedication to improving global health. Let’s continue to publish, present, share, network, and consume science to keep the momentum going.
Did you work on a recently approved drug? We would love to know about it! Share your story on the AAPS Community.