Allergy Shots in a Pill?

Allergy season’s dank fecundity might be welcomed in many parts of America this year. Anything that’s warmer. But the worst allergy sufferers might soon be headed back to the doctor’s office for another round of allergy shots. Or perhaps not.

ALK-Abelló, a Denmark-based specialty pharmaceuticals company focused solely on allergy immunotherapy products, expects FDA to approve the first “disease-modifying” allergy tablet for seasonal snifflers and long-time sneezers in the US before the end of June.

ALK CEO Jens Bager

The first two of three allergy immunotherapy products, Grastek and Ragwitek (indicated for grass and ragweed allergies, respectively), are currently undergoing FDA review. Grastek was approved in Canada earlier this month. The third product, also a sublingual, or under the tongue, tablet, will target dust mite allergies. All three products are out-licensed to Merck for commercialization in North America.

Jens Bager, CEO at ALK, said the company’s achievement is in “taking a concept that has been well understood for 90 years and moving it into a much more convenient therapy, and also moving it into the real pharmaceutical area by having a fully compliant, documented clinical path approved by FDA and health insurers.” FDA hasn’t made a final determination yet, but Merck has released product handbooks for both Grastek andRagwitek, which Bager says go far beyond the available data supporting allergy shots. “We know from many years of experience that [traditional allergy shots] do work, but we do not see any clinical evidence.”

Bager should know, given that ALK currently supplies “approximately one-third of all the allergens used by practicing American allergists.” ALK grows its own raw allergens for the US market in three local facilities. Grass pollen, ragweed and dust mites are the leading allergy antagonists in the US, says Bager, accounting for 80% of allergy symptoms. Tree pollen and Japanese cedar are the fourth and fifth most severe and common seasonal allergens globally.

Grastek is priced at roughly the equivalent of $3.50 per pill, per day, in Europe and Canada, or a little over $1,000 a year, although Bager emphasizes that this price “gives no indication of what the price will be in the US.” The recommended course of therapy, for those allergy sufferers willing to “invest in a persistent effect,” is three years, says Bager. That’s in keeping with traditional allergy shot regimens, which can run as long as five years and fifty doctor’s appointments. Bager hastens to add that ALK’s allergy immunotherapy tablets also have “a very fast onset of action, over and above what you see with traditional antihistamine treatments…if you want a symptomatic effect, you just need to treat yourself for a few weeks.”

ALK and Merck argue that allergy immunotherapy is a disease-modifying therapy, although it’s uncertain, even unlikely, based on advisory committee discussions, that FDA will go along with the use of that phrase on the label (the EMEA did include it in Europe). Bager says allergy immunotherapy can also prevent the onset of allergic asthma, and is testing this thesis with a six-year European study of 600 children suffering from allergic rhinitis. Subjects were blinded into two groups, one active and one placebo, “in order to show that we can actually prevent these kids from developing asthma,” says Bager. That study concludes in 2015; some FDA advisory committee members were skeptical of that claim as well.

ALK and Merck hope their allergy immunotherapy tablets, based on safety and efficacy data, will usher in a new era of treatment for allergy sufferers, particularly with patients who’d rather skip the hassle of showing up at the doctor’s office, or children who don’t want needles. “I see this almost as a prophylactic for children,” says Bager. “You can prevent the development and progression of hay fever, as well as the development of asthma,” he insists.

ALK will potentially face off against French biopharma Stallergenes, a self-described “world leader” in allergy immunotherapy. Stallergenes’ Oralair combines five different grass pollens – sweet vernal, orchard, perennial rye, Timothy (the pollen used in Grastek), and Kentucky Blue Grass – into one sublingual tablet. FDA reviewed Grastek and Oralair during the same meetinglast December. Both products, and also Ragwitek, have been recommended for approval by FDA’s Advisory Committee.

As of last January, Stallergenes executives expected Oralair to receive FDA approval in the first quarter of this year, meaning sometime in the next four days. With April showers just around the corner, followed soon after by May flowers, FDA’s timing with a regulatory approval for Grastek, Ragwitek and Oralair – assuming they’re all approved – could mean the difference between a shot or a pill for many allergy sufferers this season.