Robert Wood, MD

Palforzia Discontinuation Ends Only FDA-Approved Peanut OIT

Palforzia (peanut allergen powder-dnfp), the first and only 

, was officially discontinued on July 31, 2026, a timeline the manufacturer has attributed to commercial rather than safety, quality, or efficacy factors.

Robert Wood, MD, of Johns Hopkins University, who studies oral immunotherapy (OIT) outcomes in food-allergic children, said Palforzia's launch coincided with the onset of the COVID-19 pandemic, which paused in-office dose escalations for roughly a year. Prescribing requirements slowed adoption further, and clinicians increasingly turned to non-FDA-regulated peanut products for OIT once maintenance protocols proved workable outside the Palforzia framework.

“The reality is the practice of OIT has continued, and very few people out there will be missing Palforzia as a treatment option, because those who want to do peanut OIT will continue to do it with products purchased over the counter in the grocery store,” Wood said.

For patients already at a maintenance dose, Wood said transitioning off Palforzia carries limited risk, since standardized maintenance amounts, such as a fixed daily peanut-protein serving, are easier to trust from a grocery-store source than the microgram-level doses used at initiation. Risk calculus shifts most for patients still early in dose escalation, when product potency and labeling accuracy matter more.

With Palforzia off the market, omalizumab (Xolair) stands as the only FDA-approved food allergy therapy available. Wood said treatment selection now hinges heavily on how many foods a patient reacts to, since multi-allergen OIT carries a higher side-effect burden than single-food OIT.

At Johns Hopkins, Wood’s team increasingly pairs omalizumab with staged food introduction, using the biologic as daily protection while patients incorporate allergens such as milk or wheat, sometimes discontinuing omalizumab later if food tolerance holds. Wood said the decision remains family-specific, weighing the number of allergens, desired dietary goals, and tolerance for risk.

Full discussion of these treatment-sequencing questions, including perspective from Jacqueline Ross, MD, is available in 

Editor’s note: Reported disclosures for Wood include Genentech and Novartis Pharmaceuticals Corporation.

Palforzia Discontinued: Ending the Only FDA-Approved Peanut OIT. 

https://www.hcplive.com/view/palforzia-discontinued-ending-only-fda-approved-peanut-oit

. Published July 31, 2026. Accessed August 6, 2026.

With Palforzia® Ending, What’s Next for Peanut Allergy Patients? Allergy & Asthma Network. Palforzia discontinued. August 3, 2026. Accessed August 6, 2026. 

https://allergyasthmanetwork.org/news/palforzia-discontinued/

Videos

Robert Wood, MD, of Johns Hopkins University explains what the July 31 exit means for peanut oral immunotherapy and omalizumab-assisted desensitization.

Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option

Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia), the first and only FDA-approved oral immunotherapy (OIT) for 

, will be discontinued as of July 31, 2026, leaving allergists without an FDA-cleared product for patients starting desensitization.

Stallergenes Greer has said the withdrawal is not related to safety, quality, or efficacy.

 Robert Wood, MD, of Johns Hopkins University, said the drug's rocky commercial run began almost immediately after its 2020 approval.

"It got off to a very unfortunate start because it was approved in January of 2020, and the pandemic started in March of 2020," Wood said.

Palforzia's in-office dose buildups became difficult to schedule once pandemic restrictions took hold, Wood said, and cumbersome FDA prescribing requirements added friction for practices. During the same period, more allergists gained comfort compounding peanut OIT from grocery store products, drawing volume away from the branded therapy.

Palforzia's studies also documented roughly a 10% risk of anaphylaxis in the first 1 to 2 years of treatment, along with a subset of patients who discontinued due to severe gastrointestinal effects, including eosinophilic esophagitis.

For patients already at maintenance dosing, transition risk is low. Palforzia's maintenance dose delivers approximately 300 mg of peanut protein, providing cross-contamination coverage against accidental ingestion, said Jacqueline Ross, MD, of Allergy Partners of New Jersey.

Beyond OIT, Ross pointed to a broadening menu of options: omalizumab is now FDA-approved for food allergy, sublingual immunotherapy data continue to accumulate, and epicutaneous immunotherapy remains in active study.

“Very few people out there are going to be missing Palforzia as a treatment option, because those who want to do peanut OIT will continue to do it with products purchased in the grocery store,” Wood said.

With Palforzia® Ending, What's Next For Peanut Allergy Patients? Allergy & Asthma Network. Published February 19, 2026. Accessed July 30, 2026. 

Stallergenes Greer. Palforzia. Accessed July 30, 2026. 

As Palforzia exits the market on July 31, 2026, allergists Robert Wood, MD, and Jacqueline Ross, MD, outline what changes for patients already in treatment.

In a follow-up interview with HCPLive, Robert A. Wood, MD, professor of pediatrics at Johns Hopkins University School of Medicine, discussed post hoc analyses from the OUTMATCH stage 2 trial suggesting age and maintenance dosing may shape individualized counseling for multiallergen oral immunotherapy (MOIT) in 

Age, Maintenance Dosing Shape MOIT Counseling in Multifood Allergy

Promising Data from OUTMATCH Stage 2 Trial

OUTMATCH stage 2 randomized 117 participants with allergy to peanut and ≥ 2 additional foods to omalizumab or omalizumab-facilitated MOIT targeting a 1000 mg per-food maintenance dose, with omalizumab reaching greater intention-to-treat success (36% vs 19%; odds ratio [OR], 2.6; 95% CI, 1.1-6.3; 

 =.03).¹ Discontinuation reached 49% in the MOIT arm compared with 12% for omalizumab, driving much of the gap between arms.² Wood said newer analyses point toward more individualized counseling based on patient age and treatment goals.

"We've not seen a… big age difference for omalizumab, but many studies with OIT have suggested better outcomes in very young children," Wood told 

. “Younger kids may also have [fewer] side effects than older children or adolescents, so there could be a distinction in the recommendations made to a family based on patient age."

Wood noted adherence often grows harder in adolescence, as daily dosing becomes burdensome even amid minor symptoms.

OUTMATCH Post-Hoc Analysis: Reaching the Full 3000 mg Dose

A post hoc subgroup analysis found participants reaching the full 3000 mg MOIT maintenance dose had greater success than those on lower doses (54% vs 24%; 

 =.13), though the comparison was underpowered.² Wood said dosing targets often vary by allergen and family goals.

Does age affect outcomes with oral immunotherapy in multifood allergy?


Post hoc OUTMATCH stage 2 data suggest younger children may have better OIT outcomes and fewer side effects than adolescents, though the trend did not reach statistical significance.

Does reaching the full MOIT maintenance dose improve success rates?


A post hoc analysis found participants reaching the 3000 mg maintenance dose had greater success than those on lower doses (54% vs 24%; 

 =.13), though the comparison was underpowered.

“The goal of the family may be very different for one food versus another,” Wood said. “If a patient is being treated, say, for peanut, cashew, and walnut, where in most instances there's not a big desire to actually eat a lot of that food, they may tend toward lower doses because it's less cumbersome. If [the food allergy] is…milk, egg, and wheat, they may really be pushing harder for the goal of being able to introduce the food into the diet.”

Wood said both omalizumab and omalizumab-facilitated MOIT remain viable options requiring individualized risk-benefit discussion. He called for additional comparative and cost-benefit research to guide selection between the 2 strategies.²

Read part 1 of our interview with Wood here: 

Omalizumab Outperforms Oral Immunotherapy for Multifood Allergy

Wood RA, et al. Treatment of Multifood Allergy with Omalizumab or Multiallergen Oral Immunotherapy. 

Omalizumab Outperforms Multiallergen OIT for Multifood Allergy. HCPLive. 

https://www.hcplive.com/view/omalizumab-outperforms-multiallergen-oit-multifood-allergy

. Published July 30, 2026. Accessed July 30, 2026.

Robert. Wood, MD, discusses post hoc OUTMATCH stage 2 findings on age and maintenance dosing in multiallergen oral immunotherapy.

Omalizumab (Xolair) produced significantly greater treatment success than omalizumab-facilitated multiallergen oral immunotherapy (MOIT) in patients with 

new stage 2 results from the OUTMATCH trial

Omalizumab received FDA approval in 2024 as the first agent indicated to reduce the risk of allergic reactions, including anaphylaxis, following accidental exposure to 1 or more foods. Oral immunotherapy using non-FDA-approved commercial products remains common in clinical practice, but no trial had directly compared the 2 approaches before OUTMATCH. This trial enrolled 117 participants with allergy to peanuts and ≥ 2 additional foods across 10 US academic centers.¹

"Both treatments can be effective, and both will provide protection from small exposures and even the ability to start eating the food directly," Robert A. Wood, MD, professor of pediatrics, Johns Hopkins University School of Medicine, told

. "The biggest difference we found was the side effects from oral immunotherapy were such a far larger group of patients really couldn't tolerate the therapy."

Participants (median age, 7 years) were randomized to active MOIT (n = 58) or active omalizumab (n = 59) following a 16-week open-label omalizumab run-in. MOIT was escalated toward a goal maintenance dose of 1000 mg per food (3000 mg total protein), while the omalizumab arm transitioned to 44 weeks of blinded injections. The primary endpoint was cumulative tolerated dose of ≥ 4044 mg for all 3 foods on double-blind, placebo-controlled food challenge.¹

In the intention-to-treat (ITT) population, omalizumab was superior to MOIT for the primary endpoint (36% vs 19%; odds ratio [OR], 2.6; 95% CI, 1.1-6.3; 

 =.03). This difference disappeared in the per-protocol population (OR, 1.2; 95% CI, 0.5-3.3; 

 =.66), reflecting a substantially higher discontinuation rate in the MOIT arm (49%) compared with omalizumab (12%) most driven by adverse events.¹

Omalizumab Safety versus Multiallergen Oral Immunotherapy

Omalizumab also showed superiority across secondary endpoints in the ITT population, including cumulative tolerated dose of ≥ 4044 mg for ≥ 2 foods (OR, 3.3; 95% CI, 1.5-7.3; 

 =.002) and for individual foods including peanuts (OR, 4.3; 95% CI, 1.9-9.7; 

 <.001), milk (OR, 6.2; 95% CI, 1.4-27.6; 

 =.02), and eggs (OR, 11.7; 95% CI, 1.9-70.2; 

 =.004). For protection against small unintentional exposures, 72% of the omalizumab arm tolerated ≥ 444 mg of all 3 allergens compared with 39% of the MOIT arm.¹

What did the OUTMATCH stage 2 trial show?

Omalizumab produced higher treatment success than omalizumab-facilitated multiallergen oral immunotherapy in the intention-to-treat population, but the difference largely disappeared once high MOIT discontinuation rates were accounted for in the per-protocol analysis.

How does omalizumab compare with oral immunotherapy for multifood allergy?


Both approaches showed similar efficacy among participants who completed treatment, but MOIT carried significantly higher rates of serious adverse events, epinephrine-treated reactions, and anaphylaxis, driving nearly half of MOIT participants to discontinue.

Is omalizumab safe for patients with multiple food allergies?


Across the full OUTMATCH program, no anaphylactic events were attributed to omalizumab injections, and reactions were largely limited to non-dose-limiting local injection-site reactions.

The MOIT arm carried a substantially heavier safety burden, with more serious adverse events (31% vs 0%), events treated with epinephrine (37% vs 7%) and events meeting anaphylaxis criteria (27% vs 2% [than the omalizumab arm. Investigators also identified 3 cases of biopsy-confirmed eosinophilic esophagitis in the MOIT group.¹

"The adverse event profile of omalizumab is very reassuring, and this phase of the study confirmed the adverse events are very small," Wood said. "We've now, in the entirety of OUTMATCH, not seen any anaphylactic events [with omalizumab].”

However, Wood noted that omalizumab has a black box warning for anaphylaxis with an estimated risk of 1 in 500 to 1 in 1000 patients.

“What that translates to is that the first doses are given under observation,” he said.

Wood noted reactions to omalizumab in the trial were largely limited to local injection-site reactions, consistent with prior stage 1 findings, and were not dose-limiting in any participant.

The investigators pointed to protocol-imposed rigidity in MOIT dosing, including the inability to adjust individual food doses, as a possible contributor to the arm's high discontinuation rate, suggesting real-world flexibility could improve tolerability. Additional trials comparing OIT with anti-IgE strategies, including cost-benefit analyses, are needed to guide personalized treatment selection.¹

Wood RA, Togias A, Burk CM, et al. Treatment of multifood allergy with omalizumab or multiallergen oral immunotherapy: a randomized clinical trial. 

Derman C. Omalizumab Outperforms Multiallergen OIT for Multifood Allergy. HCPLive Published July 28, 2026. Accessed July 29, 2026. 

Robert Wood, MD, discusses OUTMATCH data showing omalizumab beat multiallergen oral immunotherapy, though MOIT dropouts narrowed the gap.

Robert Wood, MD

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