Vigafyde: Could the only ready-to-use vigabatrin oral solution be a Sabril alternative?

In June 2024, the FDA approved Vigafyde - the first and only ready-to-use vigabatrin oral solution ¹. This is positive news for patients with infantile spasms (West syndrome). On the one hand, it's a new formulation of an active ingredient that has been widely used in the treatment of infantile spasms. On the other hand, it comes at a time when another vigabatrin product, Sabril, is in short supply in many countries after two partial recalls in 2023 ^2,3. 

Could Vigafyde, the newest vigabatrin oral solution, be a potential Sabril alternative? Here's what you need to know.

What is Vigafyde (vigabatrin oral solution) used for?

Vigafyde (vigabatrin) is a prescription medicine for the treatment of infantile spasms in patients aged between 1 month and 2 years, if the possible benefits outweigh the potential serious risk of permanent vision loss in the baby ⁴.  

How is Vigafyde different from other vigabatrin oral solutions?

Vigafyde is not an innovative medicine per se. The active ingredient vigabatrin has been FDA approved since 2009 (and EMA approved since 1989, with some adjustments in 1999) ⁵. Vigabatrin is available under different brand names, including Sabril, Vigpoder, and Kigabeq.

However, Vigafyde differs from other available vigabatrin medicines in its form. As of July 2024, it's the only ready-to-use vigabatrin oral solution. It's highly concentrated and requires a smaller volume than other vigabratin brands to obtain the same dosage ⁶.

What is the age limit for vigabatrin oral solution?

That depends on the brand name and formulation. When used as monotherapy for infantile spasms, these are the age limitations for vigabatrin oral solution:

• Vigafyde, as a ready-to-use vigabatrin oral solution, is indicated for patients aged 1 month to 2 years;
• Sabril, as granules for oral solution, is indicated for patients aged 1 months to 2 years;
• Kigabeq, as soluble tablets, is indicated for patients aged 1 months to 7 years. 

Can Vigafyde be a Sabril alternative?

If your child or someone close to you has been affected by the Sabril recall and subsequent medicine shortage, you may be wondering whether Vigafyde could be an alternative.

Let's first have a look at the reasons behind Sabril recalls, and the differences between the two medicines. 

What caused the Sabril recalls in 2023?

There were two partial Sabril recalls in 2023. The first one, in July 2023, was triggered by spotting possible trace amounts of another prescription medicine in Sabril. The second recall, in December 2023, was triggered by a faulty pouch seal that could lead to product loss and possible underdosing ³. 

As a result,  many countries, including Australia and Canada, experienced a temporary shortage of the medicine. 

Differences between Sabril and Vigafyde

Both medicines have the same active ingredient (vigabatrin). They also both share their indication as monotherapy for infantile spasms in patients aged 1 months to 2 years. Importantly, both Sabril and Vigafyde have the same potential serious side effect of permanent vision loss.

However, there are also some differences between Sabril and Vigafyde:

• Additional indications: Sabril is also indicated for the treatment of refractory complex partial seizures in patients above the age of 2. As of July 2024, Vigafyde is not approved for this indication.
• Forms and strengths: Sabril is available as tablets (500 mg) or powder for oral solution (500 mg), whereas Vigafyde is available as a ready-to-use oral solution (100 mg/mL).
• Approvals: As of June 2024, Vigafyde is only approved by the FDA in the USA. Sabril, on the other hand, is approved by the FDA, EMA, Health Canada, Australia's TGA, and more. 

As always, the only person who can decide whether Vigafyde could be a suitable Sabril alternative for your child is their treating doctor. However, based on the comparison above, it seems possible for Vigafyde to replace Sabril, if the need is there. 

When will Vigafyde/Vigzip be approved in Europe and the UK?

While Vigafyde (marketed outside the USA as Vigzip) doesn't have EU-wide approval yet, it is approved in some European countries. As of July 2024, Vigzip is approved in Germany, France, the Netherlands, Spain, and Italy ⁷ , in accordance with the European Decetralised Procedure for Approval. However, the medicine is not yet available in any of the listed countries. Hopefully, this will be the case shortly.

At this point, it's difficult to say if and when a potential MHRA approval and a full EMA approval are coming for Vigzip.

How to get Vigafyde before its EMA or MHRA approval

If your child's doctor is considering Vigafyde as a Sabril alternative, you may not be thrilled by the prospect of waiting for Vigafyde/Vigzip's local approval or availability. Luckily, if the medicine has been prescribed to your child, you can get it faster, via Named Patient Import.

Buy Vigafyde (vigabatrin oral solution) via Named Patient Import

In most countries, patients are legally allowed to buy and import medicines that could enhance their quality of life or address life-threatening conditions. The regulation making this possible is known as Named Patient Import.

There may be variations across countries in terms of the specific administrative requirements. However, in all cases these criteria must be met:

• The medicine in question has market approval in another country and is not (yet) approved or available in the patient's country;
• There is no alternative on the local market;
• The medicine is for personal use;
• The patient has a prescription from their treating doctor;
• The doctor takes responsibility for the treatment. This might require different documentation from country to country.

Do you want to use the Named Patient Import regulation to get Vigafyde before its EU-wide approval (or its approval in the UK or elsewhere)? You will first need to consult your child's treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with buying Vigafyde immediately. Get in touch with us for more information.

References:

1. Pyros Pharmaceuticals Announces FDA Approval of VIGAFYDE™ (vigabatrin) as the First and Only Ready-to-Use Vigabatrin Oral Solution. BioSpace, 17 June 2024.
2. InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg Due to Leaking Sachets. FDA, 15 December 2023.
3. Vigabatrin. Epilepsy Foundation, 4 May 2024.
4. Pope, Carmen. Vigafyde: Uses, Dosage, Side Effects, Warnings. Drugs.com, 20 June 2024.
5. Vigabatrin — new data on indications and safety in paediatric epilepsy. Polish Journal of Neurology and Neurosurgery, Accessed 02 July 2024.
6. Park, Brian. Ready-to-Use Vigabatrin Oral Solution Approved for Infantile Spasms. eMPR.com, 18 June 2024.
7. Pyros Pharmaceuticals Announces Positive Outcome of the European Decentralised Procedure for Approval of VIGZIP™ (vigabatrin oral solution). BioSpace, Accessed 08 July 2024.