ditary angioedema (HAE).US FDAEcallantide SC injection
Kalbitor®
Dyax Corp.Ecallantide, a peptide inhibitor of plasma kallikrein, was approved for the treatment of HAE attacks. This drug is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients ≥12 years of age.US FDAIcatibant SC injection
Firazyr®
Shire CanadaA Notice of Compliance was issued for icatibant acetate ready-to-use injection for the treatment of acute attacks of HAE in adults with C1-esterase inhibitor deficiency via blockade of bradykinin at the bradykinin B2 receptor.Health CanadaMelanoma（黑素瘤）Trametinib tablet + Dabrafenib capsule
Mekinist® + Tafinlar®
GlaxoSmithKline plcAccelerated approval was granted to trametinib in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by the FDA-approved THxID™ BRAF test. Approval of the combination therapy is based on the demonstration of response rate and median duration of response in a multicenter, open-label, randomized, active-controlled, dose-ranging Phase 1/2 trial, which compared combination trametinib and dabrafenib to dabrafenib monotherapy. The overall response rate was 76% (95% confidence interval [CI]; 62, 87) with combination therapy compared to 54% (95% CI; 40, 67) with dabrafenib alone.US FDANivolumab IV infusion
Opdivo®
Ono Pharmaceutical Co.Manufacturing and marketing approval was granted to this programmed death-1 (PD-1) monoclonal antibody for the treatment of unresectable melanoma. It is the first PD-1 immune checkpoint inhibitor to gain regulatory approval. Opdivo® received accelerated US FDA approval in December 2014.MHWL (Japan)
US FDAPembrolizumab IV injection
Keytruda®
Merck & Co., Inc.Accelerated approval was granted to pembrolizumab for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. The drug acts by targeting the PD-1 receptor. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with programmed cell death 1 ligand 1 (PD-L1) and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response.US FDA
Photodermatosis
光敏性皮肤病
Afamelanotide 16 mg SC bioresorbable implants
Scenesse®
Clinuvel PharmaceuticalsThe European Medicines Agency (EMA) approved afamelanotide 16 mg implants for treating the genetic disorder erythropoietic protoporphyria (EPP), a painful photodermatosis. This photoprotective agent belongs to a family of drugs known as melanocortins and is the first ever treatment developed for EPP. Afamelanotide provides prophylactic treatment through its antioxidant effects and activation of melanin in skin, thereby providing patients with a biological barrier between their skin and the various wavelengths of light that trigger phototoxic reactions.European CommissionPsoriasis（银屑病）Apremilast tablets
Otezla®
Celgene CorporationThis orally available, first-in-class, small molecule inhibitor of phosphodiesterase-4 (PDE4) was approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Inhibition of PDE4 suppresses both TNF-α productio |
