This week’s clinical pharmacology highlights include advances in cancer therapy, long-term followup of the landmark PROACT trial comparing anticoagulation strategies after aortic replacement, and the finding that hydrocortisone may not reduce mortality in septic shock.
The US FDA has approved the antihelminthic drug moxidectin (developed by Medicines Development for Global Health) for the treatment of onchocerciasis.¹
Merck’s ivermectin, developed in the late 1970s, is the only other pharmaceutical agent approved for treating onchocerciasis. Moxidectin has outperformed ivermectin in clinical trials, demonstrating superior efficacy and comparable safety. Continue reading “Moxidectin, First New Treatment for River Blindness in 30 Years, Approved by FDA”
This week’s clinical pharmacology highlights include a new treatment for river blindness, further success for JAK inhibitors in inflammatory diseases, and the finding that more patients are taking medications associated with depressive symptoms.
The US FDA has approved tofacitinib (Xeljanz, Pfizer) for the treatment of moderate-severe ulcerative colitis (UC).
- Janus kinase inhibitor (blocks STAT transcription factor activation and inflammatory signaling)
- First oral agent approved for chronic use in UC
- 10 mg tofacitinib PO BID induced remission in 17-18% of patients (vs. 8.2% placebo) after 8 weeks
- Of patients that responded after 8 week trial, 40.6% who continued 10-mg tofacitinib for 52 weeks achieved sustained remission (versus 11.1% placebo)
- Adverse events (common): arthralgia, diarrhea, elevated cholesterol, headache, shingles, rash, and upper respiratory infection
- Adverse events (severe): malignancy (e.g., lymphoma), serious opportunistic infections (FDA black-box warnings)