New co-CEO named at WuXi; Bristol-Myers gets priority review for myeloma combo featuring Empliciti
→ Over the last 11 years, Edward Hu has been COO, CFO and chief investment officer at WuXi AppTec. Now he’s been named co-CEO, with a special responsibility for small molecule drug discovery, development, manufacturing services, drug and medical device testing services, plus some. He’s retaining his CFO responsibilities for now until a replacement is selected. And Hu will continue to report to company founder Ge Li, who’s been chiefly responsible for the rapid growth of the big China-based company.
→ Italy’s Dompé has gotten the green light to market its topical eye drop in the US. Oxervate, which treats a rare disease called neurotrophic keratitis, contains a recombinant form of the human nerve growth factor cenegermin. Across two studies, 70% of patients treated with the drug achieved complete corneal healing in eight weeks, compared with 28% in the control arm. “While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastating,” said Wiley Chambers, an ophthalmologist in the FDA’s Center for Drug Evaluation and Research, referring to common symptoms like eye pain, inflammation and watery eyes. “In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease. Today’s approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients.”
→ The FDA is giving Bristol-Myers Squibb $BMY a push as it seeks to expand usage of Empliciti in relapsed/refractory multiple myeloma. With the new priority review, the company will get a final decision by the end of the year on its combo use of Empliciti, Celgene’s pomalidomide (Pomalyst, or Imnovid, depending on where you are) and a low dose of the steroid dexamethasone. Bristol-Myers, which is co-developing the drug with AbbVie, filed the supplemental biologics license application based on a Phase II study that showed adding Empliciti to pomalidomide and dexamethasone — the current standard of care — boosted median progression-free survival by a notable margin.