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After a record-setting 45 approvals in 2015, the FDA approved only 22 new molecular entities in 2016.1 The FDA’s Office of New Drugs gave 3 explanations for the drop off: 1) 5 drugs with 2016 due dates were approved ahead of schedule in 2015; 2) biopharmaceutical companies filed fewer applications in 2016; and 3) there were more rejections. Of the 22 novel drugs, almost one third received breakthrough therapy designation, about two thirds were given priority review, and more than one third were for rare diseases. Two of the novel agents, elbasvir/grazoprevir and sofosbuvir/velpatasvir, were discussed in The Rx Consultant November 2016 issue on hepatitis C.
This issue reviews 8 novel drugs: crisaborole – the first topical phosphodiesterase 4 inhibitor for atopic dermatitis; ixekizumab – the second interleukin-17A inhibitor for psoriasis; lifitegrast – a first-in-class ophthalmic agent for dry eye disease; pimavanserin – the first drug to be approved for Parkinson’s disease psychosis; and 4 cancer drugs – atezolizumab for bladder and lung cancer, olaratumab for soft tissue sarcoma, rucaparib for ovarian cancer, and venetoclax for chronic lymphocytic leukemia Prasterone, a new option for a common postmenopausal disorder, is also reviewed. The 4 cancer drugs received accelerated approval; this means that their continued approval may depend on confirmation of benefit in further studies. Usual doses and selected drug interactions are summarized in Table 1. Nine more new drugs or new dosage forms that may be encountered in every day practice are described in Table 2. Both tables include pronunciation guides and brand names...
This program was developed by The Rx Consultant and published by Continuing Education Network, Inc. The Rx Consultant accepts no advertising or financial support from the pharmaceutical industry and is funded solely by the purchase of programs. The Rx Consultant is dedicated to providing unbiased, balanced information to health care practitioners.
Programs developed by The Rx Consultant are written by health care providers with expertise in the topic area, peer-reviewed, extensively edited, and fact-checked. This development process was created to insure that every program presents information that is current, accurate, relevant to "real world" health care providers, and written in an easy reading, "plain English" style.
The Rx Consultant is a publication of Continuing Education Network, Inc.
ACPE Universal Activity Number: 0428-0000-17-003-H01-P
Chief Editor and CE Administrator
Terry M. Baker, PharmD
Tracy Farnen, PharmD
James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Associate Clinical Professor
Richard Ron Finley, B.S. Pharm.,R.Ph.
Consult Pharmacist Aging and Adult Health Services
Julio R. Lopez, PharmD, FCSHP
Adjunct Clinical Professor
Assistant Clinical Professor
Visiting Associate Professor and Lecturer
Pamela Mausner, MD
Helen Berlie, Pharm.D. CDE, BCACP
Ambulatory Care Specialist - Diabetes
Senior Editorial Advisor
Gerard Hatheway, PharmD, PhD
Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Angie S. Graham, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD
Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners
Meuleman, RN, C, MS
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