Hay fever sufferers will have a new option this spring with Wednesday’s FDA approval of Greer Laboratories Inc.’s Oralair, the first under-the-tongue allergen extract approved in the U.S. to treat allergic rhinitis with or without conjunctivitis.

The oral immunotherapy will provide to U.S. patients an at-home alternative to injection treatments that has been available in Europe for years.

Oralair will be available nationwide in May, said John Roby, Greer’s CEO and president. But final pricing for the new drug is still a week or two away as the company continues to negotiate with managed care providers.

“It’s a process of education, introducing immunotherapy to them, and educating them around both the short-term or long-term benefits,” Roby told BioWorld Today.

Lenoir, N.C.-based Greer is ramping up its marketing staff for the launch, but Roby said that as an allergy-focused company, it already had most of the sales infrastructure and relationships it will need in place.

The FDA approval triggers a $10 million payment to Greer’s manufacturing partner and Oralair’s originator, Stallergenes SA. The Antony, France-based company could receive up to $120 million in regulatory and sales-based milestones from its U.S. commercialization agreement with Greer. Stallergenes will receive an undisclosed transfer price for the tablets and stands to receive sales royalties on the product as well. (See BioWorld Today, Nov. 1, 2013.)

Though Oralair launches without immediate U.S. competition, before long it will likely face down Alk-Abello A/S and Merck & Co. Inc.’s Grastek sublingual tablet, an investigational therapy that received unanimous backing from the FDA’s Allergenic Products Advisory Committee just a day after the committee considered Oralair. (See BioWorld Today, Dec. 13, 2013.)

Both therapies have been approved in Europe for years, with Stallergenes gaining approval for Oralair in 2008 and Grazax (Grastek’s European trade name) approved in 2006.

In 2013, Stallergenes reported that sales of Oralair hit €22.2 million (US$30.6 million), with the drug gaining a global market share of 45 percent in the grass pollen tablet segment, according to IMS data for countries where both Oralair and Grazax are available. Projected sales of Grazax climbed to $37 million in 2013, according to Thomson Reuters Cortellis Competitive Intelligence.

There are about 30 million people in the U.S. with allergic rhinitis with or without conjunctivitis, with about 3 million of them using immunotherapy injections. Grass allergies are the most common seasonal allergy in the U.S. and most people are allergic to more than one type of grass. That could give Oralair an advantage over products that incorporate just one grass type, such as Grastek, Roby suggested.

During treatment for one grass pollen season, patients taking Oralair experienced a 16 percent to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo.

Oralair is the only FDA-approved oral allergy immunotherapy tablet that includes a five-grass, mixed-pollens allergen extract. It contains extracts from sweet vernal grass (Anthoxanthum odoratum), orchard grass (Dactylis glomerata), perennial rye grass (Lolium perenne), Timothy grass (Phleum pratense) and Kentucky bluegrass (Poa pratensis). The active ingredient in Grastek is extract from Timothy grass pollen.

Patients prescribed Oralair will need to start taking the once-daily tablet four months before the start of the grass pollen season, which generally runs May to August in the U.S., and continue using it throughout the season. The first dose is taken at the health care provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions. Patients will also be prescribed an auto-injectable epinephrine pen as an extra precaution.

Oralair’s prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur. Roby said that was expected and prudent, given that the product is in a new class. Within the year, Stallergenes will initiate a postmarketing safety study.

The most common adverse reactions to Oralair reported by adults were itching in the ears and mouth and of the tongue, as well as swelling of the mouth and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.