New ALS Drug Coming to Israel in First Distribution Deal outside North America
2 min read
Israel is about to become the first country to use a new drug for ALS outside North America and it is believed to help in extending the lives of the patient by nearly a year.
With its headquarters in Petah Tikva, Neopharm has made a distribution deal with Amylyx Pharmaceuticals based in Massachusetts.
The drug
In accordance with the deal, the company will be able to distribute the drug in Israel, Gaza and the West Bank, which has been marketed as Relyvrio. The drug is currently only available in Canada and the United States.
On Tuesday, Amylyx issued a statement that announced the deal with Neopharm and said that it could be an ‘important step’ in rolling out the drug in Africa, Europe and the wider Middle East.
ALS is a disease that has proven to be relentlessly progressive that occurs due to muscle neuron death in the spinal cord and brain.
This fatal neurodegenerative disorder causes muscle function to deteriorate, renders patients unable to speak or move, causes respiratory paralysis and eventually results in death.
According to clinical data, the drug AMX0035 has proven to be effective in slowing down the disease’s progression.
The results
Amylyx said that trials involving the drug showed that it was capable of increasing survival of patients by an average of 10.6 months.
Dr. Babar Khokhar is a neurologist at Yale University, but not connected to Neopharm or Amylyx. He wrote in a briefing that the trial data shows that the drug can slowdown the decline by almost 25%.
In September, the American Food and Drug Administration (FDA) gave its approval for AMX0035, but it is still pending review after clinical testing on a wider scale.
However, it should be noted that it has become one of the three drugs that have been given the greenlight to be used for ALS treatment.
The other drugs that have been approved include Radicava in 2017 and Rilutek that had gotten the greenlight back in 1995.
It is possible to take AMX0035 with other medications for ALS and a lot of doctors are hoping that it can complement their benefits.
More details
On Thursday, the medical director of Neopharm, Dr. Michael Abrahamy said that there was a great deal of excitement in the field.
He added that treatments were needed by the ALS community because the disease takes away the independence of patients and they are bound to a wheel chair.
It also has a high mortality rate due to which slowing down its progression is exciting. The new drug is administered orally and is aimed at preventing the death of neurons, which can help in slowing down the disease.
The FDA had approved the drug based on the clinical data that showed the medication could slowdown ALS.
Before it can be locally distributed in Israel, Neopharm would have to get the approval of the Ministry of Health in Israel.
However, it is very rare for a drug that the FDA has approved to be rejected in Israel.
