CPE
Mark S. Johnson, PharmD, MACE, BCPS
FDA approved 50 new (“novel”) drugs in 2024 that had not been approved or marketed in the United States. These new drugs are classified as new molecular entities under New Drug Applications or as new therapeutic biologics under Biologics License Applications.
Of these new drugs, 26 (52%) received orphan drug designation because they are used in the treatment of patients with rare diseases, cancers, or tumors. Other relevant designations of the new drugs included breakthrough therapies (36%), priority review (56%), fast-track designation (44%), accelerated review (14%), and first-in-class (48%). Also approved in 2024 were 18 biosimilars (not included in the new drugs designation) for eight reference products, which was more than in any previous years.
Seven new therapeutic agents are considered in this review, the second in a two-part series of articles on new therapeutic agents approved in 2024. Drugs chosen are based on disease states that may be more commonly seen.
These new drugs include: vadadustat (Vafseo—Akebia Therapeutics, Inc.), donanemab-azbt (Kisunla—Eli Lilly and Company), xanomeline and trospium chloride (Cobenfy—Bristol Myers Squibb), sofpironium (Sofdra—Botanix Pharmaceuticals Ltd.), epinephrine nasal spray (neffy—ARS Pharmaceuticals), lebrikizumab-lbkz injection (Ebglyss—Eli Lilly), and nemolizumab-ilto for injection (Nemluvio—Galderma).
Following the review of each new therapeutic agent, a summary for each agent and its place in therapy compared to existing drugs on the market is provided. Comparisons are identified at the time the new drug is first marketed and do not reflect later approval of additional new drugs and/or changes that occur.
CPE assessment
This assessment must be taken online; please see “CPE information” below for further instructions. The online system will present these questions in random order to help reinforce the learning opportunity. There is only one correct answer to each question.
CPE information
To obtain 1 hour of CPE credit for this activity, complete the CPE exam and submit it online at www.pharmacist.com/education. A Statement of Credit will be awarded for a passing grade of 70% or better. You have two opportunities to successfully complete the CPE exam. Pharmacists and technicians who successfully complete this activity before August 1, 2028, can receive credit. Your Statement of Credit will be available online immediately upon successful completion of the CPE exam.
This policy is intended to maintain the integrity of the CPE activity. Learners who successfully complete this activity by the expiration date can receive CPE credit. Please visit CPE Monitor for your statement of credit/transcript.
To claim credit
1. Go to http://apha.us/CPE.
2. Log in to your APhA account, or register as a new user.
3. Select “Enroll Now” or “Add to Cart” (click “View Cart” and “Check Out”).
4. Complete the assessment and evaluation.
5. Click “Claim Credit.” You will need to provide your NABP e-profile ID number to obtain and print your statement of credit.
Assistance is available Monday through Friday from 8:30 am to 5:00 pm ET at APhA InfoCenter by calling 800-237-APhA (2742)
or by e-mailing infocenter@aphanet.org.