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Products

Date: 2017-04-16

Type of information: Granting of a Market Authorisation in the EU

Product name: Acarizax®/Miticure™ (house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet)

Compound: house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet)

Therapeutic area: Allergic diseases - Immunological diseases

Action mechanism: sublingual allergy immunotherapy tablet/immunotherapy product

Company: ALK Abello (Denmark) Merck&Co (USA - NJ)

Disease: house dust mite allergic rhinitis and allergic asthma

Latest news: • On April 16, 2017, ALK announced that its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet Acarizax® has had its approval in 12 European countries expanded to include the treatment of adolescent patients with HDM induced allergic rhinitis. The expanded approval, which covers patients who are aged 12-17, is based upon data from clinical trials conducted in Japan and North America as part of the global Acarizax® clinical development programme. The results confirmed the favourable efficacy, safety and tolerability profile of Acarizax® and were in line with previous studies in adults. As a result of this announcement, Acarizax® is now approved for use in adolescents in Austria, Czech Republic, Denmark, Finland, Italy, the Netherlands, Norway, Poland, Sweden, Slovakia, and the key European markets of France and Germany. • On April 13, 2016, ALK’s partner for North America, Merck&Co announced that the FDA has accepted the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for review. The product has been already approved in 11 European countries, where it is known as Acarizac®. The product has also been launched in Japan, where it is marketed by Torii under the brand name Miticure™. ALK’s partnership with MSD covers the development, registration and commercialisation of a portfolio of allergy immunotherapy tablets in North America. • On February 10, 2016, ALK announced that its partner for North America, Merck&Co has submitted a Biologics License Application (BLA) to the FDA for its house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet). The application to the FDA is based on results from an extensive clinical development programme that has involved approximately 4,400 patients in North America and Europe and has already seen the product approved in 11 European countries, where it is known as Acarizax®.  The submission of the BLA entitles ALK to a minor non-disclosed milestone payment. The payment does not change ALK’s financial outlook for 2016 as the outlook is based on EBITDA before sales royalties and milestone payments from partners. ALK announced that authorities in France have issued a marketing authorisation for ALK’s new house dust mite sublingual allergy immuno­therapy tablet (SLIT-tablet), Acarizax®. The product was recently launched in Germany and Denmark. Moreover, the recent, temporary suspension of production by ALK’s main competitor has led to a shortage of supply for many doctors and allergy immunotherapy patients, especially in France. As the suspension continues and more allergy sufferers need to renew their prescriptions, the number of affected patients is expected to increase. • On December 9, 2015, ALK announced that it has obtained reimbursement in Denmark for its new product Acarizax® for the treatment of house dust mite allergic rhinitis and allergic asthma. Acarizax® is the second SLIT-tablet that ALK launches in Denmark, Grazax® against grass pollen allergy being the first. Acarizax® will be on the market in the beginning of 2016. • On November 26, 2015, ALK announced that the sublingual allergy immunotherapy product Miticure™ now will be available for prescription in Japan for adults and adolescents (12-64 years) who suffer from house dust mite allergic rhinitis. Miticure™ has been placed on the Japanese National Health Insurance reimbursement list and will be launched in the beginning of December 2015. • On September 28, 2015, ALK announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application for the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet Miticure™. Miticure™ is indicated in adults and adolescents (12-64 years) as hyposensitisation therapy (allergy immunotherapy) for the treatment of allergic rhinitis caused by house dust mites. • On August 31, 2015, ALK announced that it has successfully completed the registration procedure for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet in 11 European countries (Austria, Czech Republic, Denmark, Finland, France, Germany, Italy, Norway, Poland, Slovakia and Sweden). The HDM SLIT-tablet is indicated in adult patients (18-65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions: - Persistent moderate to severe HDM allergic rhinitis despite the use of symptom-relieving medication - HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis and where patients' asthma status has been carefully evaluated. Following the completion of the registration procedure, ALK expects the product to become available in the first European markets within the next six months, once local market access negotiations have been completed. • On January 26, 2015,  ALK announced that its partner, Torii, has submitted a New Drug Application in Japan for ALK's house dust mite sublingual allergy immunotherapy tablet for the indication of allergic rhinitis. ALK's partnership with Torii covers the develop­ment, registration and commercialisation of the HDM SLIT-tablet and a SLIT-tablet against Japanese cedar pollen allergy, which is currently in Phase II/III clinical development. It also includes collaboration on a HDM injection-based immunotherapy product and HDM diagnostic product which have recently been approved for marketing by the authorities. The application is based on Japanese Phase III data that demonstrated efficacy in HDM allergic rhinitis. Subject to approval, the HDM SLIT-tablet could reach the market in Japan in 2016. The HDM SLIT-tablet is also currently under review by the European authorities. ALK submitted a registration application in November 2014 and the European regulatory process is expected to take approximately 12 months. In North America, ALK's partner Merck & Co, is currently conducting a Phase III clinical trial to investigate the safety and efficacy of the HDM SLIT-tablet in the treatment of HDM allergic rhinitis. The trial is expected to be completed in 2015 and is intended to form the basis for a registration application. ALK intends to conduct further clinical trials with the HDM SLIT-tablet to allow access to China and other emerging markets. Additional clinical development in the coming years is expected to also include trials to support paediatric use and the prevention of allergic asthma. • On November 20, 2014, ALK Abello announced that a registration application for the house dust mite sublingual allergy immunotherapy tablet has been submitted in Europe. House dust mites are the most common cause of respiratory allergic disease, affecting an estimated 35 million adult Europeans of whom more than 3 million are poorly controlled with current standard pharmacotherapy. ALK's regulatory filing for the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet has been accepted for review by the European health authorities via the Decentralised Procedure with Germany as the Reference Member State. The regulatory review process is expected to take around 12 months, which means that, subject to approval, the first launches could possibly take place in 2016. ALK’s regulatory filing is supported by a clinical development programme involving approximately 3,000 patients. Data from the clinical trials demonstrated efficacy in both HDM allergic asthma and HDM allergic rhinitis. The pivotal Phase III MITRA trial in HDM allergic asthma demonstrated that the tablet significantly reduced patients’ risks of moderate or severe asthma exacerbations. Measured as a hazard ratio, patients treated with the 12 SQ-HDM dose experienced a 34% reduction in the risk of suffering moderate or severe asthma exacerbations compared with placebo treated patients during reduction of inhaled corticosteroids. This included a 36% reduction in the patients' risk of experiencing nocturnal awakenings and/or increased daytime symptoms due to their asthma5. The pivotal Phase III MERIT trial in HDM allergic rhinitis involved patients who were highly symptomatic despite regular use of pharmacotherapy. The trial demonstrated that the tablet significantly reduced patients' rhinitis symptoms and medication use. Patients treated with the 12 SQ-HDM dose experienced a 22% reduction in the median combined symptom and medication score compared with the placebo group. This effect represents an additional benefit on top of the effect provided by pharmacotherapy since all treatment groups had free access to guideline-recommended pharmacotherapy during the entire trial. Moreover, the treatment reduced the patients’ risk of experiencing days with rhinitis exacerbations by 50% (defined as a day impacted by severe allergic rhinitis symptoms). Both the MITRA and MERIT trials demonstrated that the treatment was well tolerated.  

Patents:

Submission of marketing authorization application USA : 2016-02-10

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2015-08-31/2017-04-16

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes