Novartis: OmalizumabAchieved all Targets in Phase III Safety Registration

Novartis: OmalizumabAchieved all Targets in Phase III Safety Registration

An announcement made by the Swiss drugmaker Novartis AG (NVS: Quote) on Wednesday suggested about the late-breaking results omalizumab clearing all the primary and secondary endpoints of a pivotal Phase III safety registration study in chronic spontaneous urticaria or CSU.

It is a chronic and debilitating form of hives with partial approved treatment options. GLACIAL is considered as the second of three pivotal Phase III studies. These studies conduct analysis about the efficacy and safety of omalizumab in CSU.

The result derived from the study supported supported the efficacy, safety and tolerability of omalizumab in patients with refractory CSU. It is a kind of chronic and debilitating skin disease with obstinate itch and hives.

Near about 40 percent of CSU patients were unsuccessful on ntihistamines. These include those who were taking the approved dose even for the fourth time. The doses, in terms of official regulations are currently available only for treatment for CSU.

However, Omalizumab is presently not at all approved or indicated for CSU. Supervision of the submissions for omalizumab in CSU is scheduled for later times in the current year. It is a collaborated effort of Novartis and Genentech, Inc.

The data was brought forward for the first time at the European Academy of Allergy and Clinical Immunology-World Allergy Organization World Allergy and Asthma Congress 2013 in Milan which is located in Italy.


FrenchTribune Specials

BMW offering faster and smaller auto-battery chargers to i3 EV owners

In a recent announcement, German engineering giant BMW said that is offering faster and smaller auto-battery chargers - dubbed the i DC 24KWh fast chargers - to the owners of the company's i3 electric cars.

According to the announcement made by BMW, the i DC 24KWh fast charger has been designed by the company, in collaboration with Bosch...

Most Popular

Astronauts Preparing for Asteroid Mission in Underwater Lab

Four US astronauts have been reportedly living 19 meters...

Web cam Captures Loggerhead Sea Turtles’ Hatchings

On Friday, hatchings of hundreds of tiny loggerhead sea...

Hepatitis C’s Genotype-1 to be Prevalent Globally

Published in journal Hepatology, a new study has...

Poll

Can Greece Come out of Economic Problems: