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...
- Pharmacy Technicians
- Nurse Practitioners
This CE activity was developed by The Rx Consultant, a publication of Continuing Education Network, Inc.
CE activities for Pharmacists and Pharmacy Technicians:
This continuing education (CE) activity meets the requirements of all state boards of pharmacy for approved continuing education hours. CE credit is automatically reported to CPE Monitor.
CE activities for Nurse Practitioners and Clinical Nurse Specialists:
This continuing education activity meets the requirements of:
The American Nurses Credentialing Center (ANCC) for formally approved continuing education (CE) hours, and CE hours of pharmacotherapeutics.
The American Academy of Nurse Practitioners Certification Program (AANPCP) for acceptable, accredited CE.
This is a pharmacotherapeutics/pharmacology CE activity.
Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Requirements for CE Credit
- For each of the drugs reviewed: List the FDA approved indication(s), state the recommended dose(s), and discuss the evidence supporting the drug’s approval and potential role(s) in therapy.
- For each of the drugs reviewed: Describe significant side effects and drug interactions. Provide 2-3 patient counseling tips.
- For each drug listed in Table 2: List the generic/brand names, dosage form(s), FDA approved indication(s), and major safety concerns.
James Chan, Pharm.D., PhD
Brief Bio : James Chan, PharmD, PhD, Pharmacy Quality and Outcomes Coordinator, Kaiser Permanente, Oakland, CA and Associate Clinical Professor, School of Pharmacy, University of California, San Francisco, CA.
Pamela Mausner, MD
Brief Bio : Pamela Mausner, MD; Medical Writer/Editor and Healthcare Advocate; and Associate Editor, The Rx Consultant.