Get the content you want anytime you want.

An Overview of Infectious Disease Medications Approved in 2016 and Outlook Through 2017



Gilead’s Odefsey (emtricitabine/rilpivirine HCl/ tenofovir alafenamide fumarate), which was approved on March 2, 2016, is indicated for treatment of HIV-1 infection in patients 12 years and older. Two of three components of Odefsey are identical to those of an earlier fixed-dose antiviral, Complera (emtricitabine/ rilpivirine HCl/tenofovir disoproxil fumarate). Patients receiving the combination containing tenofovir alafenamide fumarate showed lower rates of bone mineral density loss, and lower rates of proteinuria than patients receiving the combination containing tenofovir disoproxil fumarate.6-8
A two-drug combination, Descovy (emtricitabine/ tenofovir alafenamide fumarate) was approved approximately 1 month after Odefsey, on April 4, 2016. Unlike Odefsey, Descovy is not indicated for use as a single-tablet regimen, but is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. In clinical trials, compared with its tenofovir disoproxil fumarate– containing counterpart, Truvada (emtricitabine/ tenofovir disoproxil fumarate), Descovy showed lower rates of bone mineral density loss and superior renal outcomes.6,9-11
Additionally, approval for an existing medication, the CCR5 co-receptor antagonist Selzentry (maraviroc), was extended on November 4, 2016, when the treatment was approved for use in children aged 2 years or older weighing at least 10 kg. Previously, the medication was only indicated for use in adults aged 18 years or older.1,12,13


On November 10, 2016, Gilead received approval for Vemlidy (tenofovir alafenamide) for treatment of chronic HBV infection in patients with compensated liver disease. Compared with Viread (tenofovir disoproxil fumarate), which is also approved for treatment of chronic HBV infection, Vemlidy is more stable in plasma, delivers tenofovir to liver cells more efficiently, and has demonstrated improved renal and bone laboratory safety parameters versus Viread in clinical studies.14,15
Although it has not yet been approved, a new vaccine for hepatitis B—Dynavax’s Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted])—is expected to be approved by the end of the year, based on a prescription drug user fee act (PDUFA) date of December 15, 2016. Results of phase 3 trials with Heplisav-B indicate that the medication may offer earlier protection against HBV infection with fewer doses than existing vaccines.16


Reformulations of existing medications approved as new drugs include Aczone (dapsone) gel 7.5% (Allergan), which was previously available only in the 5% strength; Acticlate (doxycycline hyclate) tablets (Aqua) for acne vulgaris, which has been available in the United States since 1967; and Otovel (ciprofloxacin HCl/fluocinolone acetonide) drops (Arbor), which substitutes the glucocorticoid component in existing ciprofloxacin-containing combination drops for a different corticosteroid.17-19
Contrasting with these products, medications that represent important advances include Elusys’ Anthim (obiltoxaximab solution), a monoclonal antibody product that was approved for treatment of inhalational anthrax; PaxVax’s Vaxchora (cholera vaccine, live oral) for prevention of disease caused by Vibrio cholerae serogroup O1 in adults aged 18 through 64 years traveling to cholera-affected areas; and Merck’s Zinplava (bezlotoxumab) for reducing Clostridium difficile infection (CDI) recurrence in patients 18 years of age or older at a high risk for CDI recurrence receiving antibacterial drug treatment of CDI.20-22
Looking forward to FDA decisions in late 2016 and early 2017, prospects for infectious disease approvals are, unfortunately, relatively paltry. An FDA decision on Dynavax’s Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]) is expected December 15, 2016, followed by Cempra’s Solithera (solithromycin) for community-acquired bacterial pneumonia on December 27, 2016. At this time, a PDUFA date has been assigned for only one other product with an infectious disease indication (ozenoxacin cream 1% by Medimetriks for impetigo).16,23,24 

Big advances in treatment can