Oralair, GrasTek, Ragwitek

[twinturbo]

Anyone in Canada on Oralair? We can't get it in USA yet.
 

The Food and Drug Administration in April approved two tablets from Merck, Grastek for grass pollen and Ragwitek for ragweed, plus a grass pollen tablet called Oralair from Stallergenes.

Drugmaker Merck & Co. has a tablet for house dust mite allergies in final patient testing that could hit the market in two or three years, and it's considering other therapies. France's Stallergenes SA is testing a tablet for birch tree allergies and, with partner Shionogi & Co. Ltd. in Japan, tablets for allergies to dust mites and Japanese cedar pollen. Britain's Circassia Ltd. has a cat allergy treatment in final testing and six others in earlier testing

With the new tablets, as they dissolve, the grass extract inside drains into lymph nodes in the neck, which produce protective antibodies against the effects of pollen that's inhaled or gets in the mouth. Since the extract is unlikely to enter their blood, patients need only be watched the first time, then can take the pills at home.

[twinturbo]

Shionogi Pipeline
Actair, House dust mites sublingual immunotherapy tablet (S-524101)
S-524101
Sublingual tablet of house- dust mite allergen extracts for immunotherapy
Allergic rhinitis caused by house-dust mite allergen
Japan: NDA submission (Apr. 2014)
Stallergenes SA (France)

Stallergenes reports positive results in the phase II/III clinical trial of house dust mite immunotherapy tablets in Japan
 
Antony (France), 3 February 2014 – STALLERGENES S.A (Euronext Paris) today announced the completion of a phase II / III clinical study (S-524101) of its sublingual immunotherapy tablet for the treatment of house dust mites related allergic rhinitis, conducted in Japan by its partner Shionogi & Co. Ltd..
The randomized, double-blind and placebo-controlled S-524101 study evaluated the efficacy and safety of a 12 month course of treatment. Shionogi reported that the study achieved its primary efficacy endpoint, as the treated groups have demonstrated a statistically significant difference on the Average Adjusted Symptom Score over one year of treatment versus the placebo group. Overall, the safety and tolerability profile were favorable.
“We are very pleased with the results of this study, which represent an important step forward in the clinical development of our house dust mite sublingual immunotherapy tablet in Japan”, said Roberto Gradnik, Chief Executive Officer of STALLERGENES. “This represents a major achievement resulting from our successful partnership with Shionogi & Co. Ltd., which may lead to Japanese allergy sufferers having access to new and innovative solutions”.
A New Drug Application (NDA) in Japan is planned within the first half of the next Japanese fiscal year (ending March 2015).

Allergic rhinitis affects 25%1  of Japan’s population and asthma 6.7%2 . House dust mites and Japanese cedar pollen are the two main causes of respiratory allergies. From early childhood, house dust mites can trigger allergic rhinitis, which worsens over time with a natural progression towards asthma. The symptoms may be severe, significantly impairing patients’ quality of life.

Merck Grastek sheet

Pediatrics
Safety data are based on 3 clinical trials which randomized 881 subjects between 5 and 17 years of age with grass pollen induced rhinitis with or without conjunctivitis. Overall, 445 subjects received at least one dose of GRASTEK. Of the subjects treated with GRASTEK, 31% had mild asthma and 86% were sensitized to other allergens in addition to grass. The subject population was 86% White, 7% African American and 3% multi-racial. The majority (66%) of subjects were male. The mean age of subjects was 11.7 years. Subject demographics in placebo-treated subjects were similar to the active group.
The most common adverse reactions in pediatric subjects treated with GRASTEK were oral pruritus (24.4% vs 2.1% placebo), throat irritation (21.3% vs 2.5%) and mouth edema (9.8% vs 0.2%). The percentage of subjects who discontinued from the clinical trials because of an adverse reaction while exposed to GRASTEK or placebo was 6.3% and 0.7%, respectively.
One pediatric subject (1/447; 0.2%) who received GRASTEK experienced a treatment-related systemic allergic reaction consisting of lip angioedema, slight dysphagia due to the sensation of a lump in the throat, and intermittent cough which was of moderate intensity on Day 1. The subject was treated with epinephrine, recovered, and was discontinued from the trial.

Postmarketing Safety Studies
In European post-approval studies which included 1,666 patients treated with GRASTEK (marketed under the name GRAZAX), reported serious adverse reactions assessed as related to GRASTEK use included anaphylactic reaction, asthma exacerbation, hoarseness, laryngitis, oral ulceration, and ulcerative colitis exacerbation.
Included in these reports was an adult male with asthma who experienced anaphylactic shock within two minutes of administration of GRASTEK. The patient experienced depressed level of consciousness, hypotension, increased heart rate, wheezing, urticaria, and face edema.

[twinturbo]

http://www.stallergenes.nl/fileadmin/images/public/Press_releases_nieuws/GB_Actair_27_08_09.pdf

[spacecanada]

My husband sees his GP next Monday (a week from tomorrow) and I will ask him to ask about it.  He has severe seasonal allergies to grass/pollens/snow mould and could really benefit form this.  I'll push to find out more if possible and report back if I learn anything new.

[twinturbo]

As long as he's looking into it anyhow, yes I would appreciate anything you could forward back here. I'm considering the grass for myself and dust mites for the little guy once it's out and once he's older. SLIT + mites was a tremendous part of the Asia Pacific Allergy conference so I am not at all surprised Shionogi is developing it with Stallergenes, who not so coincidentally also had a presence at the same AP Allergy congress.