| Name/Company | Approval Dates/Comments |
| Dabrafenib + trametinib in combination Tafinlar®+Mekinist® Novartis |
In April 2018, the US FDA approved the oral regimen of dabrafenib in combination with trametinib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutation, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Adjuvant therapy may be recommended for patients with melanoma at high-risk of recurrence after surgical resection. |
| Certolizumab pegol for SC injection Cimzia® Sorrento/Scilex |
The FDA approved a label extension in May 2018 for certolizumab pegol to include a new indication for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Certolizumab pegol is a monoclonal antibody directed against tumor necrosis factor-α. The approval also follows a FDA label update in March 2018 for Cimzia® that includes pharmacokinetic data showing negligible to low transfer of the biologic through the placenta and minimal mother-to-infant transfer from breast milk. |
| Ubidecarenone injectable nanosuspension BPM 31510 Berg, LLC |
In May 2018, the FDA granted orphan-drug designation to ubidecarenone for the treatment of patients with epidermolysis bullosa (EB), a rare, pervasive and debilitating connective tissue disorder for which there is currently no FDA-approved treatment or cure. BPM 31510 is a nanodispersion containing the benzoquinone ubidecarenone (coenzyme Q10), with potential protective, antioxidant and antineoplastic activities. |
| Diacerein 1% ointment CCP-020 Castle Creek |
The FDA granted rare pediatric disease designation for diacerein 1% ointment in May 2018 for the treatment of epidermolysis bullosa. Diacerein and its active metabolite rhein inhibit production and activity of interleukin-1β and other proinflammatory cytokines. The safety and efficacy of CCP-020 is currently being evaluated in the DELIVERS study for the treatment of patients with epidermolysis bullosa simplex, a subtype of EB. |
| Ixekizumab for SC injection Taltz® Eli Lilly & Co. |
In May 2018, the FDA approved a label update for ixekizumab, a humanized monoclonal anti-IL-17A antibody, to include data on psoriasis involving the genital area. The approved label update is based on results from a Phase 3b double-blind trial of 149 patients with moderate-to-severe genital psoriasis who were randomized 1:1 to receive ixekizumab or a placebo. At 12 weeks, patients treated with ixekizumab demonstrated significant improvement in the severity of psoriasis affecting the genital area, genital itch, and the patient-perceived impact of psoriasis involving the genital area on frequency of sexual activity. |
| Hyaluronic acid (HA) dermal filler Restylane® Lyft® Nestlé Skin Health |
The FDA approved this HA-based dermal filler in May 2018 for the correction of age-related volume loss in the back of the hands for patients >21 years of age. Restylane® Lyft is the first and only HA filler to be approved for restoring fullness to the back of the hands. |
| Rituximab for IV use Rituxan® Genentech/Roche |
In June 2018, the FDA approved this CD20-directed cytolytic antibody for treating adults with moderate-to-severe pemphigus vulgaris. The FDA’s decision was based on data from the Ritux 3 trial, a randomized, controlled study comparing rituximab plus short-term corticosteroid vs. corticosteroid monotherapy. Primary efficacy endpoints were met, with 90% of patients treated with the Ritux 3 regimen achieving complete remission after 24 months without the use of corticosteroids for ≥2 months vs. 28% of patients using corticosteroids alone. |
