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Is Hyrnuo available in the UAE? Status, route and cost

A plain answer for families in the UAE, checked against FDA, regulator and manufacturer sources on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026.

Is Hyrnuo available in the UAE?

Hyrnuo is not in Abu Dhabi's official drug code list (checked 17 October 2026), and its federal UAE status is unverified. It is a twice-daily tablet for HER2-mutant non-squamous lung cancer. The usual legal route is a hospital import request: the treating hospital asks for approval to import it for one patient, using the FDA approval.

Registration: Not in Abu Dhabi's drug code list (26 September 2026 release); federal status unverified.
Access route: Hospital import request to EDE for one named patient, using the FDA approval.
Who acts: your treating hospital in the UAE (licensed by DoH in Abu Dhabi, DHA in Dubai, or the federal system in the other emirates), on the request of your treating specialist.
Timeline: We give you a written timeline estimate for your case before you commit.
Price: Medicine price: quote on request. You get a written quote for your case before you commit.

Status in the UAE, with dates

Hyrnuo (sevabertinib) was not found in the Abu Dhabi Department of Health drug code list, release of 26 September 2026, checked 17 October 2026. (source)
Hyrnuo was also not found in SFDA's public Drugs List in Saudi Arabia on 17 October 2026. (source)
FDA accelerated approval for previously treated patients on 19 November 2025. (source)
FDA widened the indication to patients without prior systemic therapy on 9 September 2026. (source)

What Hyrnuo is

Hyrnuo (sevabertinib) is a tablet made by Bayer. It is for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, found with an FDA-authorized test.

The FDA first approved it on 19 November 2025, under accelerated approval, for patients who had already received a systemic therapy. Accelerated approval was based on tumor response rate and how long responses lasted. On 9 September 2026 the FDA widened the indication so that it no longer requires prior systemic therapy. In the SOHO-01 trial, 75% of 69 patients who had not had systemic therapy had a confirmed tumor response, and 73% of those responses lasted at least 6 months.

How it is given and safety

The dose is 20 mg by mouth twice daily with food, until the cancer grows or side effects become unacceptable. It is a tablet, so after the prescription it can be taken at home under the oncologist's follow-up.

The FDA lists warnings for diarrhea, liver toxicity, lung inflammation (interstitial lung disease or pneumonitis), weaker heart pumping, eye problems, raised pancreatic enzymes and harm to an unborn baby. At the first approval, Bayer reported the most common side effects as diarrhea (87%), rash (66%), nail-fold infection (paronychia, 33%), mouth sores (stomatitis, 29%) and nausea (21%).

How access works in the UAE

For a medicine that is not registered, the treating hospital asks for approval to import it for a specific patient. The hospital signs an undertaking that it takes responsibility for the medicine's use and shows that the medicine is registered in its country of origin. FDA approval makes this easier. The medicine stays inside the hospital system and cannot be resold.

Hospitals in Abu Dhabi are licensed by the Department of Health (DoH), and hospitals in Dubai by the Dubai Health Authority (DHA). Your hospital pharmacy knows which office handles the file for your hospital today.

The Abu Dhabi list covers coded products in that emirate, and we could not check the federal EDE directory. Ask the hospital pharmacy to confirm the current status with EDE and, for Abu Dhabi or Dubai hospitals, with DoH or DHA.

Who does what

Your treating specialist decides whether Hyrnuo is right for the patient and writes the clinical letter and prescription.
The hospital files the import request, receives the medicine and dispenses it to the patient.
The Emirates Drug Establishment (EDE) registers medicines and decides on any import request for a medicine that is not registered.
Bayer makes Hyrnuo and decides where it is supplied.
Reserve Meds helps your family understand the steps, organizes records and communication, and, where an import is approved, arranges US supply through our licensed wholesale partner. We do not give medical advice.

Documents you will usually need

The tumor test report showing a HER2 (ERBB2) TKD activating mutation (the US label requires an FDA-authorized test; ask your oncologist how the local test compares)
Pathology confirming non-squamous NSCLC, and recent scans
A list of past cancer treatments, if any
For an import request: the hospital's request form, its signed declaration of responsibility, written patient consent, and proof of the US FDA approval (we can supply the US prescribing information)

Steps

Doctor's letter. Your specialist writes the clinical letter and prescription.
Hospital request. The hospital pharmacy files the import request with EDE.
Regulator decision. EDE reviews the request and approves it or asks for more information.
US sourcing. Our US-licensed wholesale partner supplies the medicine, shipped with tracking.
Hospital receipt. The hospital pharmacy receives the medicine and dispenses it to the patient.

Timeline and cost

We give you a written timeline estimate for your case before you commit. The regulator, the hospital and the manufacturer set their own timelines.

Medicine price: quote on request. You get a written quote for your case before you commit. Your total cost depends on the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate access to FDA-approved medicines only. We help your family understand the route, organize records and communication with the doctor and hospital, and, where an import is approved, arrange US supply and shipping through our licensed wholesale partner. Delivery follows the terms of the import approval and is confirmed in writing before you commit. We do not prescribe, and we do not decide what EDE approves.

Ask about Hyrnuo in the UAE

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

Is Hyrnuo registered in the UAE?

Hyrnuo is not in Abu Dhabi's official drug code list (checked 17 October 2026), and its federal UAE status is unverified. The Abu Dhabi list covers coded products in that emirate, and we could not check the federal EDE directory. Ask the hospital pharmacy to confirm the current status with EDE and, for Abu Dhabi or Dubai hospitals, with DoH or DHA.

How do patients in the UAE get Hyrnuo?

The Emirates Drug Establishment (EDE) is the UAE's federal medicines regulator. It was created by Federal Decree No. 28 of 2023 and took over the medicines role of the Ministry of Health and Prevention (MOHAP). Medicines normally have to be registered before they are used. For a medicine that is not registered, the treating hospital asks for approval to import it for a specific patient. The hospital signs an undertaking that it takes responsibility for the medicine's use and shows that the medicine is registered in its country of origin. FDA approval makes this easier. The medicine stays inside the hospital system and cannot be resold.

How long does it take to get Hyrnuo in the UAE?

We give you a written timeline estimate for your case before you commit. The regulator, the hospital and the manufacturer set their own timelines, and we tell you honestly what depends on them.

How much does Hyrnuo cost?

Medicine price: quote on request. You get a written quote for your case before you commit. Your total cost, including shipping, import steps and coordination, is quoted in writing before you commit. No hidden charges.

Who can take Hyrnuo?

On the US label, adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors carry a HER2 (ERBB2) tyrosine kinase domain activating mutation, found with an FDA-authorized test. Since September 2026, prior systemic therapy is no longer required. Your oncologist decides whether it fits your case.

Sources

Checked on 17 October 2026. Regulator rules and lists change. Your doctor, hospital pharmacy or the regulator confirms the current position before anything is filed.