Australia’s Therapeutic Goods Administration has approved Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of allergic rhinitis and rhinoconjunctivitis, Glenmark Pharmaceuticals said. The marketing application was submitted by Seqirus, which acquired Australian commercialization rights to the nasal spray in July 2018. Glenmark said that it will manufacture Ryaltris for Seqirus at its manufacturing facility in Baddi, India.
According to Glenmark, the anticipated Australian launch will be the first for Ryaltris. The company, which said that it plans to commercialize Ryaltris “in several markets globally, either on its own or through partnerships,” has previously announced that Yuhan Corporation will commercialize the nasal spray in South Korea and that Grandpharma will commercialize Ryaltris in China. In the US, the FDA issued a complete response letter to the company’s NDA for Ryaltris in June 2019.
Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said, “We are delighted to receive an approval from TGA for Ryaltris through our partner Seqirus to commercialize Ryaltris in Australia. Seqirus’ strong presence in allergy in this market makes them an ideal partner for Glenmark.”
Seqirus VP Asia Pacific Commercial Operations Lorna Meldrum commented, “We are very excited to be working with Glenmark on the distribution, marketing and sales of their novel fixed dose combination product for allergic rhinitis. Ryaltris is an important addition to Seqirus’ growing product range and strengthens our broad portfolio of in-licensed pharmaceuticals and vaccines in Australia.”
Read the Glenmark Pharmaceuticals press release.
