7 Drugs Approved for Primary Care: Q2 2024
As another quarter rounds out, a new batch of drugs have been approved by the US Food and Drug Administration for conditions often seen in primary care - quite a few of them first-in-class or novel in another way. For example, the first and only pneumococcal vaccine formulated specifically to protect adults 50 years and older; the first mRNA vaccine against RSV for adults aged 60 years and older; and the first inhaled product with a novel mechanism of action approved for maintenance chronic obstructive pulmonary disease (COPD) treatment in over 20 years. In the slides below, we recap these drugs and 5 more.
Pneumococcal disease: Pneumococcal 21-valent conjugate vaccine (Capvaxive) injection, formerly V116, is the only pneumococcal vaccine formulated specifically to protect adults 50 years and older from invasive pneumococcal disease. The novel vaccine includes 8 unique serotypes that are not currently covered by FDA-approved pneumococcal vaccines: 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B. (Approved 6/17/24, Merck)
For full prescribing information, please click here.
Respiratory syncytial virus (RSV): mRESVIA (previously mRNA-1345) injection, is the first mRNA technology-based vaccine against lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older to be approved by the FDA. (Approved 5/31/24, Moderna, Inc)
For full prescribing information, please click here.
Chronic obstructive pulmonary disease (COPD): Ensifentrine (Ohtuvayre™) inhalation suspension, is a first-in-class selective dual inhibitor of phosphodiesterase (PDE) 3 and PDE4 indicated for the maintenance treatment of COPD in adults. The recommended dosage is 3 mg twice daily administered via oral inhalation using a standard jet nebulizer with a mouthpiece. (Approved 7/26/24, Verona Pharma plc)
For full prescribing information, please click here.
Opioid overdose: Naloxone hydrochloride (Rezenopy®) 10 mg nasal spray, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is not a substitute for emergency medical care. (Approved 4/19/24, Summit Biosciences Inc.)
For full prescribing information, please click here.
Urinary tract infection (UTI): Pivmecillinam (Pivya), is a penicillin class antibacterial indicated for the treatment of women 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus s. aprophyticus. It is the first new antibiotic to be approved for uUTI in the US in 2 decades. (Approved 4/24/2024; Utility Therapeutics Ltd.)
For full prescribing information, please click here.
Plaque psoriasis, psoriatic arthritis: Ustekinumab-aekn (Selarsdi®) injection, is a human interleukin-12 and -23 antagonist indicated for the treatment of adults and children 6 years and older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. It is a biosimilar to ustekinumab (Stelara®). (Approved 4/16/24, Alvotech and Teva Pharmaceuticals)
For full prescribing information, please click here.
Crohn disease: Vedolizumab (Entyvio®) subcutaneous injection, is an integrin receptor antagonist indicated in adults for the maintenance treatment of moderate-to-severe Crohn disease after they have completed intravenous induction therapy with a biologic. It was approved in September 2023 for the maintenance treatment of adults with moderate-to-severe active ulcerative colitis. (Approved 4/18/24, Takeda Pharms USA)
For full prescribing information, please click here.
Missed last quarter's drug roundup? Check out 7 Drugs Approved for Primary Care: Q1 2024
