| Name/Company | Approval Dates/Comments |
| Tildrakizumab-asmn for SC injection Ilumya™ Sun Pharmaceutical |
The US FDA approved tildrakizumab in March 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. Treatment is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. The FDA’s approval was based on results of two pivotal phase III trials (reSURFACE 1 and 2). These studies included about 1,800 patients and explored the efficacy and safety of tildrakizumab for treatment of patients with moderate-to-severe chronic plaque psoriasis in comparison with placebo or comparative drug, such as etanercept (Enbrel®), for up to 3.5 years. Findings showed that tildrakizumab induced 75% improvement in Psoriasis Area and Severity Index (PASI 75) in more than 60% of patients, compared with only 6% of patients on placebo. Improvement continued for up to 64 weeks after treatment. |
| Lidocaine topical system 1.8% for postherpetic neuralgia ZTlido™ Sorrento/Scilex |
In February 2018, the FDA approved this transdermal anesthetic formulation for the treatment of nerve pain associated with an outbreak of shingles, post-herpetic neuralgia (PHN). The medicated patch is covered with a 1.8% dosing of lidocaine. The proprietary adhesion technology allows the patch to remain on a person for about 12 hours, even during exercise. |
| Secukinumab for SC injection Cosentyx® Novartis |
In February 2018, the FDA approved a label update for secukinumab to include treatment for moderate-to-severe scalp psoriasis. Secukinumab, launched in 2015, is the first and only fully human interleukin-17A (IL-17A) antagonist approved to treat moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. The label update is effective in the US immediately. The regulatory decision was based on data from the phase III SCALP trial, a randomized, double-blind, placebo-controlled study that evaluated efficacy and safety in 102 patients with moderate-to-severe scalp psoriasis. Patients were randomized to receive either subcutaneous 300 mg secukinumab or placebo for 4 consecutive weeks, followed by monthly administration for the next 12 weeks. Data showed that 56.9% of the IL-17A inhibitor group was able to achieve a score of clear or almost clear, compared to 5.9% in the placebo group. |
| Vaginal gel for prevention of urogenital chlamydia
Amphora® |
In February 2018, the FDA granted Fast Track designation for Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel to prevent urogenital chlamydia infection in women. This investigational new drug is being developed for the prevention of certain sexually transmitted infections and as an on-demand, non-hormonal vaginal contraceptive. A phase IIb/ III clinical trial of Amphora® for the prevention of urogenital chlamydia and gonorrhea in women and a phase III clinical trial of Amphora® for the prevention of pregnancy are underway. In addition to Amphora® receiving Fast Track designation from the FDA for the prevention of urogenital chlamydia in women, it is designated as a Qualified Infectious Disease Product (QIDP) by the FDA for the prevention of urogenital gonorrhea infection in women. |
