Most Read Articles
Stephen Padilla, 31 Jan 2020
The combination of ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (DMR) delivers faster responses, better response rates and greater satisfaction compared with monotherapy in patients with severe rosacea, a recent study has shown.
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. 
Stephen Padilla, 08 Apr 2020
An antiparasitic drug approved by the Food and Drug Administration (FDA) has been found to be effective in stopping the growth of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a laboratory experiment, according to a collaborative study.

Romilkimab delivers in diffuse cutaneous systemic sclerosis

15 Oct 2020

Romilkimab, a novel bispecific immunoglobulin-G4 antibody that binds and neutralizes interleukin (IL)-4/IL-13, shows promise in the treatment of diffuse cutaneous systemic sclerosis (dcSSc), producing significant reduction in skin fibrosis, according to data from a phase II trial.

Ninety-seven adult dcSSc patients with or without immunosuppressive background therapy were randomized to receive either romilkimab (n=48) or placebo (n=49) for 24 weeks.

The primary endpoint of change in modified Rodnan skin score (mRSS) at week 24 was significantly greater with the study drug than with placebo (–4.76 vs –2.45; difference, –2.31, 95 percent confidence interval, –4.32 to –0.31; p=0.0291).

There were no significant differences observed in the secondary endpoints of forced vital capacity (–10 mL with romilkimab vs –80 mL with placebo; p=0.10), diffusing lung capacity for carbon monoxide (–0.12 vs –0.27, respectively; p=0.14), and physical/functional disability (mean Health Assessment Questionnaire-Disability Index score, –0.09 vs –0.12, respectively; p=0.40).

Treatment-emergent adverse event were comparable between romilkimab and placebo (80 percent vs 84 percent), with most events being mild to moderate in severity and rarely leading to discontinuations (three overall).

There were two deaths documented, one due to scleroderma renal crisis in the active treatment group and the other due to cardiomyopathy in the placebo group, but neither was considered treatment related. There were no cardiac safety signals detected with romilkimab.

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Most Read Articles
Stephen Padilla, 31 Jan 2020
The combination of ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (DMR) delivers faster responses, better response rates and greater satisfaction compared with monotherapy in patients with severe rosacea, a recent study has shown.
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. 
Stephen Padilla, 08 Apr 2020
An antiparasitic drug approved by the Food and Drug Administration (FDA) has been found to be effective in stopping the growth of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a laboratory experiment, according to a collaborative study.