Date: 2012-03-08
Type of information:
Product name: Ragwitek™
Compound: Ragweed AIT
Therapeutic area:
Action mechanism: Ragwitek® contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek® is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek® at home.
Company: Merck&Co (USA) ALK (Denmark)
Disease: ragweed pollen induced allergic rhinitis (hay fever)
Latest news: * On May 15, 2014, ALK announced that its ragweed sublingual allergy immunotherapy tablet, which is licensed to Merck for North America, has now been launched in Canada. The product is known in Canada as Ragwitek™.The launch announcement follows regulatory approval from the Canadian authorities of the New Drug Submission (NDS). In Canada, Ragwitek™ is indicated for reducing the signs and symptoms of moderate to severe seasonal short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults confirmed by clinically relevant symptoms for at least two pollen seasons and a positive skin prick test and/or a positive titre to Ambrosia artemisiifolia specific IgE, and who have responded inadequately, or are intolerant to conventional pharmacotherapy. * On April 17, 2014, the FDA has approved Ragwitek® as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. This immunotherapy is approved in adults 18 years through 65 years of age. The safety and effectiveness of Ragwitek® was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek®; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek® experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo. Ragwitek® is manufactured for Merck by Catalent Pharma Solutions Limited, United Kingdom. Merck&Co and ALK Abello have concluded a partnership which covers the development, registration and commercialisation of a portfolio of sublingual allergy immunotherapy tablets in North America. Ragwitek® is the second of these products to be approved by the FDA. Grastek®/Grazax® has been also approved in April. The third tablet, the house dust mite SLIT-tablet, is in Phase III. The US approval of Ragwitek® entitles ALK to a milestone payment from Merck. Consequently, ALK is updating its financial outlook for 2014. The milestone payment will be booked as revenue from SLIT-tablets in North America and ALK now expects operating profit (EBITDA) to be up to DKK 400 million (previously 375-400) before special items, income from product supply, and potential sales royalties in North America. * On January 28, 2014, ALK has announced that the Allergenic Products Advisory Committee of the FDA has voted that the available data support the efficacy and safety of Merck's Ragwitek™. Ragwitek™ is the proposed US trade name of the ragweed sublingual allergy immunotherapy tablet, licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK. The FDA is currently reviewing Merck's Biologic License Application (BLA) for Ragwitek™ for the treatment of ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age. FDA review of the BLA for Ragwitek™ is expected to be concluded during the first half of 2014. * On December 26, 2013, ALK has announced that the FDA has scheduled an FDA Allergenic Products Advisory Committee meeting to be held on 28 January 2014 to discuss the Biologic License Application (BLA) for the investigational ragweed sublingual allergy immunotherapy (AIT) tablet. * On May 8, 2013, ALK's partner for North America, Merck&co, has announced that the FDA has accepted the Biologics License Application (BLA) for its ragweed allergy immunotherapy tablet (AIT) for review. Merck submitted the BLA, for a tablet against ragweed allergy, to the FDA in March 2013. * On March 11, 2013, Merck&Co has submitted a Biologics License Application (BLA) to the FDA for a marketing authorisation for ragweed allergy immunotherapy tablet (AIT). ALK’s partnership with Merck&Co covers the development, registration and commercialisation of a portfolio of AITs in North America. The application to the FDA is based on results from an extensive clinical development programme. Data from the clinical trials have demonstrated that treatment with ragweed AIT reduces patients’ allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated. Merck&Co has already presented several sets of phase III data in November 2011 at the annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston and in March 2012, at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in Orlando, USA.The submission of the BLA entitles ALK to a milestone payment of $ 5 million from Merck. This payment has already been included in ALK’s financial outlook for 2013 and consequently, this announcement does not lead ALK to change its financial outlook for the year. * On March 5, 2012, ALK announced that its partner in North America, Merck&Co, plans to file registration applications for Ragweed AIT and Grass AIT with the FDA in 2013.
Patents:
Submission of marketing authorization application USA : 2013-03-11
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-04-17
UE authorization:
Favourable opinion UE:
Favourable opinion USA: 2014-01-28
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
