When new medicines are announced, it’s natural to wonder:
“If they’re better than what we already have, why can’t everyone start using them straight away?”
Two new antifungal drugs — Olorofim and Fosmanogepix — are generating real excitement because they work in completely new ways and could help people whose fungal infections no longer respond to existing treatments.
But before any new drug becomes widely available, it must go through a careful process to make sure it’s safe, effective, affordable, and used in the right patients. Here’s why most people with aspergillosis will still be treated with existing antifungal medicines for now.
🧪 1. They’re Still Being Tested
Olorofim and Fosmanogepix are still classed as investigational medicines.
That means they have shown promise in early studies — especially for severe or drug-resistant infections — but they are not yet approved for general medical use.
Regulators such as the MHRA (UK), EMA (Europe), and FDA (USA) require large, carefully controlled studies to confirm:
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that the drugs are safe for different types of patients,
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that they work as well as or better than existing treatments, and
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that the benefits clearly outweigh any risks.
Until that evidence is complete, they can only be prescribed within clinical trials or under special compassionate-use programmes at specialist hospitals.
💨 2. Different Types of Aspergillosis Need Different Treatments
Aspergillosis isn’t one single disease. It includes:
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Invasive aspergillosis, a dangerous infection in people with weak immune systems.
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Chronic pulmonary aspergillosis (CPA), a long-term infection in people with lung damage.
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Allergic bronchopulmonary aspergillosis (ABPA), an allergic reaction rather than a true infection.
The new antifungals are currently being tested only for invasive aspergillosis — the most severe form.
They haven’t yet been studied in chronic or allergic forms like CPA or ABPA, so we don’t yet know if they would work or be safe for those conditions.
💊 3. Current Medicines Still Work Well for Most Patients
Existing antifungal drugs such as itraconazole, voriconazole, posaconazole, and isavuconazole remain effective for most people with aspergillosis.
Doctors already know:
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how to monitor their levels in the blood,
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how to manage side-effects, and
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how to combine them safely with other medicines.
New drugs can bring new possibilities — but they can also bring unknown side-effects or interactions. Doctors need strong, long-term evidence before changing large numbers of patients to new treatments.
💷 4. Cost and Access Take Time
Developing antifungal drugs takes years and costs millions of pounds.
When a new medicine is finally approved, it is often very expensive at first.
In the UK, every new treatment must go through NICE (the National Institute for Health and Care Excellence).
NICE checks:
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how well it works,
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how safe it is, and
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whether the NHS can afford to provide it fairly to all who need it.
Only once NICE recommends a drug can NHS England fund it for routine use — and even then, it may be limited to certain hospitals or patient groups at first.
⚖️ 5. A Step-by-Step Approach Keeps Patients Safe
New medicines are introduced gradually — starting with people who have no other treatment options.
If they prove safe, effective, and affordable in that group, their use can be expanded step by step to include more patients and other forms of disease.
This careful rollout protects patients from unexpected risks and helps prevent early resistance, so the drugs stay effective for longer.
🧭 6. Who Decides When a New Antifungal Can Be Used for CPA?
Bringing a new antifungal from its first approval to wider use in chronic diseases like CPA involves several levels of decision-making:
1️⃣ The Manufacturer
Companies such as Shionogi Europe (Olorofim) or Basilea/Pfizer (Fosmanogepix) design the trials and decide which conditions to test first — usually the most life-threatening ones.
If early results are good, they can plan new studies for CPA or other chronic lung infections.
2️⃣ Clinical Researchers and Specialist Centres
Centres such as the National Aspergillosis Centre (NAC) collect real-world data from patients who receive these drugs through compassionate-use programmes.
If several patients with CPA improve, these results may encourage formal CPA-specific trials.
3️⃣ Regulatory Authorities
Bodies such as the MHRA (UK), EMA (Europe), or FDA (USA) decide which diseases a drug can officially be marketed for.
To add CPA as a licensed use, the company must submit:
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new clinical trial data,
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long-term safety information, and
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a formal request to extend the drug’s licence.
Until that happens, doctors can only prescribe it for CPA off-label — usually within strict hospital governance systems.
4️⃣ NICE and NHS England
Even after regulatory approval, NICE must review cost and benefit before the NHS can fund the drug for CPA.
Without a positive NICE recommendation, it can’t be routinely prescribed in the UK.
5️⃣ Specialist Clinical Networks
Finally, once approved and funded, expert groups like the NAC and national respiratory networks decide how and when the drug should be used — for example:
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only for patients with azole-resistant CPA,
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after all standard options have failed, and
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with careful monitoring.
This information is then built into national and local treatment guidelines.
🔄 Example Pathway: Olorofim’s Future Use for CPA
| Stage | Who acts | What happens |
|---|---|---|
| 1️⃣ | Shionogi | Gains approval for invasive aspergillosis |
| 2️⃣ | NAC & academic partners | Report successful CPA case studies |
| 3️⃣ | Shionogi + NAC | Launch a formal CPA clinical trial |
| 4️⃣ | MHRA / EMA | Extend licence to include CPA |
| 5️⃣ | NICE | Reviews cost-effectiveness for CPA |
| 6️⃣ | NHS England | Approves CPA use in NHS centres |
🩸 In Summary
| Reason | Why we can’t all switch now |
|---|---|
| Still in trials | Not yet fully approved for use |
| Different diseases | Only tested for invasive aspergillosis so far |
| Known vs unknown | Established drugs work well for most people |
| Cost and access | NHS approval and funding take time |
| Safe rollout | New drugs introduced step-by-step |
🌱 Looking Ahead
Both Olorofim and Fosmanogepix represent the most promising antifungal advances in decades.
If they continue to perform well in trials, they could become vital options for people whose infections no longer respond to standard medicines — and, in time, for chronic conditions like chronic pulmonary aspergillosis (CPA).
For now, the safest and most effective approach remains to use proven antifungals under expert supervision, while keeping a close watch on these exciting new developments.
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