Johnson & Johnson's S1P1 regulator Ponvory (ponesimod) is about to be approved in the EU

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting approval of Ponvory (ponesimod), which is a once-daily, orally administered drug , Selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease determined by clinical or imaging features.

Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months.

In terms of US regulation, in March 2021, Ponvory has been approved by the FDA for the treatment of adult patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive type Multiple Sclerosis (SPMS).

It is worth mentioning that Ponvory is the first and only oral disease modification therapy approved by the US FDA to conduct a controlled study on the marketed oral therapy.

Aubagio is an oral drug of Sanofi.

Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system, which is characterized by demyelination and loss of axons, leading to nerve damage and severe disability.

CHMP’s positive review opinions are based on the results of the head-to-head Phase III OPTIMUM study (NCT02425644).

It is worth mentioning that the OPTIMUM study is the first large-scale controlled head-to-head study comparing two oral medications for the treatment of RMS.

The specific data are: (1) In terms of the primary endpoint, from baseline to the 108th week of treatment, compared with the Aubagio treatment group, the annual recurrence rate (ARR) of the ponesimod treatment group was statistically significantly reduced by 30.

Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system, affecting 2.

The symptoms of relapsing multiple sclerosis (RMS) vary from person to person and may change or fluctuate over time.

The active pharmaceutical ingredient of Ponvory is ponesimod, which is a new, oral, selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, which can functionally inhibit the activity of S1P protein and bind lymphocytes to lymph nodes In order to reduce the number of circulating lymphocytes that can cross the blood-brain barrier.

At present, the sphingosine-1-phosphate (S1P) receptor has become an important target for the development of new drugs in the MS field.

After Ponvory goes public, it will compete directly with Mayzent and Zeposia.

Original Source: Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features