Genentech announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval.
While experimental desensitization strategies are available in research settings, people with food allergies must avoid known allergens and are advised to carry injectable epinephrine to prevent potentially life-threatening allergic reactions caused by accidental exposures. To help alleviate this risk, a new study to evaluate an experimental treatment for food allergy launched today.
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I imagine this post will be shared with many relatives and friends. Thank you for posting the most recent research here! (my first question was, "does this mean people should run out and try this combined therapy?" and my second was, "Hmm. I have a small child and I wonder what the side effects of this drug would be on her physical, neurological, and hormonal development if she did this.." Thanks again for all your work here, I absolutely love and trust this site!
Hi A-Ma, This type of treatment is still undergoing research studies and is not being performed in allergy clinics across the country yet. The drug described in this study is actually an injectable medicine for asthma that has not been proven/approved for use in other allergic diseases yet. It is currently only approved for use in children over age 12. The concerns you mentioned about side effects and how it may affect the child are all great questions that will be investigated as the...
I understand that Xolair is experimental for children with food allergies and only for kids 12 and up. But it is my understanding that OIT and SLIT is being done in regular clinic settings and not just in clinical trials . Is the any hospital/ clinic in the country that is doing OIT or SLIT for children with fish allergies? I have seen it only for nuts, milk and eggs. Thanks for any information you have.
Whenever I want to check to see who is doing what in research, I look at www.clinicaltrials.gov Putting in food allergies yields 374 results - that includes studies that are not yet recruiting and those that are done.. https://www.clinicaltrials.gov...es&Search=Search I am not sure about regular clinic settings - I just reread your question.
Hi; DD is fragile atopic; the idiopathic uticatia dx was used to fast track xolair approval. Long story, involving immune dysfunction and NIH, but she’s on cell cept now and feeling better. That would not typically be a path for a fa kid.
To follow: for allergies she is on Zyrtec, budesonide nasal, pazeo, eucrisa, various topical steroids, dulera, spiriva, and prn duoneb, Benadryl, hydtoxyzine, epinephrine. Has hashimotos and iatrogenic adrenal insufficiency too. Plus pots and migraines. So, other meds for those.
Hugs, Michele! Your story is a great reminder that we are all unique, and each medication has its own risks and benefits that can differ from patient to patient. So glad she's doing better now, and I know the reaction had to be plenty scary!
So I believe this approval means it can be used in general as a protection against anaphylaxsis from food on its own and then also in conjunction w/ OIT. Anyone know if there is still a 6 year old age minimum? looking/googling
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