Aurinia Pharmaceuticals received approval from the Food and Drug Administration on Friday night to market a new drug for patients with lupus nephritis, a serious autoimmune kidney disease. This is good news for patients, but the nature of the approval also makes it particularly good news for Aurinia and investors.
While the approval of the new drug, called Lupkynis, was awaited, the FDA allowed Aurinia to include its own dosing instructions in its prescription label. The dosing instructions help doctors customize Lupkynis treatment for patients with lupus nephritis, but it also strengthens and enhances the patent protection of the drug.
Unlock this article by subscribing to STAT + and enjoy your first 30 days for free!
START
What is it?
STAT + is the premium entry service of STAT for in-depth coverage and analysis of biotechnology, pharmaceutical, policy and life science coverage. Our award-winning team covers news about Wall Street, policy developments in Washington, early scientific breakthroughs and results of clinical trials, and disruption of health care in Silicon Valley and beyond.
What is included?
- Daily reporting and analysis
- The most comprehensive operational coverage of a powerhouse of reporters
- Subscriber newsletters only
- Daily newsletters to inform you about the most important industry news of the day
- STAT + talks
- Weekly opportunities to engage with our reporters and leading industry experts
- Exclusive business opportunities
- Access to premium networking networking events across the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the healthcare industry
- And much more
- Exclusive interviews with industry leaders, profiles and premium tools, such as our CRISPR Trackr.