The Competition and Markets Authority (CMA) said it had preliminarily considered that the two companies “exploited a loophole by de-branding the drug known as Epanutin prior to September 2012,” such that its price couldn’t be regulated like other branded drugs.

This provisional decision by the CMA came after the 2020 directive given by the U.K. Court of Appeal which said that the authority’s investigation, which it did earlier, was “insufficiently deep or intense.”  According to CMA, the re-investigation of the case started in June 2020 after court’s ruling, the previous year.

The Chief executive officer of CMA stated, ”Thousands of patients depend on this drug to prevent life-threatening seizures as a result of their epilepsy… This is a matter that is important for the government, for the public as patients and taxpayers, and for the pharmaceutical industry itself.”

In 2016, Pfizer was fined 84.2 million pound and Flynn 5.2 million pounds by the U.K. watchdog, for as much as 2600% rise in prices of the unbranded versions of anti-epilepsy drug, in September, 2012.

Prior to the adoption of final decision, Pfizer seems to have a possibility to respond to the CMA’s statement of objections. It said that it “continues to co-operate fully with the CMA’s ongoing investigation.”

The company, in an emailed statement, said, “Ensuring a sustainable supply of our products to U.K. patients is of paramount importance to Pfizer and Flynn Pharma was at the heart of our decision to divest the product in 2012.”  However, no spokesperson from the other company responded to the request to express their stance.

Epidiolex helps treat seizures, which is an oral solution consisting of highly purified cannabidiol. Exceptional results yielded from the safety and efficacy data obtained from the phase III trials carried out by the European Commission Decision Reliance Procedure (ECDRP), paved way for the approval of the drug. 49% reduction in seizures had been noted among the patients using the said treatment. On the other hand, only 27% reduction was observed in the placebo group.

In different organs including brain, skin, kidneys, heart and eyes, the growth of benign tumors is usually caused by a rare genetic condition known as TSC, the severity of which can vary considerably. So according to the company, it has been a leading cause of the genetic epilepsy.

Louise Fish, Chief Executive Officer of Tuberous Sclerosis Association (TSA), said, “One in every two people living with TSC-related epileptic seizures has difficult to treat epilepsy that does not respond to traditional anti-epileptic drug.”

He further added, “We are excited to see this new medicine approved by the MHRA, which gives people living with TSC and their families hope. We desperately need further options for clinicians who are managing seizures associated with TSC, and we therefore welcome this decision by MHRA.”