Catalyst

Slingshot members are tracking this event:

FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
Importance
High Medium Low
Impact on Stocks
RHHBY Community voting in process

Additional Information

Additional Relevant Details
  • Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma
  • Asthma is one of the most common long-term diseases in children, affecting about 6.3 million people younger than 18 in the U.S.
  • More than 200,000 allergic asthma patients have been treated with Xolair since its approval in 2003 for people 12 years and older3
http://www.gene.com/...
Clinical Data Efficacy and Safety FindingsThe 52-week study evaluated the safety and efficacy of Xolair as an add-on therapy in children from six to 11 years old with moderate to severe allergic asthma who were inadequately controlled despite the use of inhaled corticosteroids with or without the use of other controller asthma medications. During the first 24 weeks of treatment, steroid doses remained constant from baseline. This was followed by a 28-week period during which inhaled corticosteroid adjustment was allowed. The primary efficacy variable in this study was the rate of asthma exacerbations during the 24-week, fixed steroid treatment phase. An asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least three days and/or treatment with rescue systemic corticosteroids for at least three days4.At 24 weeks, the Xolair treatment group had a statistically significantly lower rate of asthma exacerbations compared to the placebo treatment group (0.45 vs. 0.64, respectively), representing a 31 percent relative rate reduction (rate ratio 0.69, 95 percent CI (0.53, 0.90) p=0.007)4. During the entire 52-week treatment period, the difference in asthma exacerbation rates between the Xolair and placebo treatment groups (0.78 vs. 1.36, respectively) represented a 43 percent relative rate reduction (rate ratio 0.57, 95 percent CI (0.45, 0.72) p<0.001)4.In clinical studies with pediatric patients six to 11 years old, the most common side effects (≥3 percent in Xolair-treated patients and more frequent than placebo) were common cold symptoms (nasopharyngitis), headache, fever (pyrexia), upper abdominal pain, sore throat (pharyngitis streptococcal), ear discomfort (otitis media), intestinal infection causing abdominal pain, nausea and vomiting (viral gastroenteritis), insect bites (arthropod bites) and nose bleeding (epistaxis)4.
http://www.gene.com/...
Slingshot Insights Explained
Catalyst Date
Occurred on:
Jul 07, 2016
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Omalizumab, Xolair, Allergic Asthma