trending Market Intelligence /marketintelligence/en/news-insights/trending/vCgvFBzDsByWMUlF8VYu6A2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

Alnylam seeks US FDA approval for rare kidney disease treatment

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Alnylam seeks US FDA approval for rare kidney disease treatment

Alnylam Pharmaceuticals Inc. started a rolling submission of a new drug application to the U.S. Food and Drug Administration for approval of its experimental therapy lumasiran for a rare kidney disorder.

The Cambridge, Mass.-based biotech is developing lumasiran to treat primary hyperoxaluria type 1, or PH1, a disorder in which a substance called oxalate builds up in the kidneys. Oxalate is normally filtered through the kidneys and excreted in the urine, but when combined with calcium, the nutrient forms the main component of kidney and bladder stones.

Alnylam Vice President Pritesh Gandhi said the company expects to get an approval for lumasiran from the FDA in late 2020.

SNL Image

The application will include results from a recently completed phase 3 trial called Illuminate-A in which lumasiran performed better than placebo in reducing 24-hour urinary oxalate excretion. The company was evaluating the drug in patients with PH1, ages six and above.

Alnylam is also evaluating lumasiran in a phase 3 trial called Illuminate-B in patients with PH1 who are less than six years old.

The FDA also granted the drug pediatric rare disease designation for the treatment of PH1. Lumasiran holds orphan-drug tags from the U.S. and the European regulatory agencies in addition to the FDA's breakthrough-therapy designation and the European Medicines Agency's priority medicines designation.

Alnylam plans to seek approval for the drug from the EMA in early 2020.