Month: September 2024

……….. catching up on FDA Approvals

The FDA recently approved a new therapy, Ohtuvayre (ensifentrine) from Verona Pharma plc, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.  Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ohtuvayre is administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

COPD causes difficulty in breathing and affects approximately 16 million people in the US.   

According to the CDC, COPD is the sixth leading cause of death in the United States. 

Ohtuvayre is the first new treatment for the inflammatory condition in over a decade. Two pharma competitors (Regeneron and Sanofi) are working on similar anti-inflammatory therapies. Ohtuvayre has a low side effect / adverse reaction profile.

CLICK HERE to access prescribing information

Verona Pharma said Ohtuvayre will launch at a wholesale price of $2,950 per month / +-$35,000 annually.

The company did not disclose plans for distribution. 

Given that the potential patient population is quite large and annual cost is in the specialty pharmacy territory, we anticipate that Ohtuvayre will launch in open distribution or through a multi-SP LD network.

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US FDA New Drug Application Approval of Ohtuvayre (ensifentrine) for the Maintenance Treatment of COPD 

CLICK HERE to read the press release

……….catching up on FDA approvals

We usually don’t report on expanded indications for a therapy previously approved by the FDA.

This time one such approval is noteworthy.

It is not uncommon that a new therapy comes to market and, within months, then applies for an expanded indication. There is a pattern wherein the initial NDC is often for a rare / orphan condition that is fast-tracked enabling supplemental filings to also be fast-tracked. The new approval of Kevzara is a clear exception to that rule.

Way back in 2017 the FDA approved Kevzara (sarilumab), from Sanofi, indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. Clinical trials started post-approval to include juvenile arthritis. 

Like the Energizer Bunny….. Sanofi kept going and going and going  in the ensuing 7 years to expand the 2017 indication….. and succeeded. They finally received approval for the treatment of individuals with active polyarticular juvenile idiopathic arthritis (pJIA). pJIA is a form of arthritis that affects multiple joints at one time.

As Kevzara is a sub-q therapy, specialty pharmacies may be alert to distribution opportunities.

CLICK HERE to access prescribing information

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FDA Approves Sarilumab for Active Polyarticular Juvenile Idiopathic Arthritis

CLICK HERE to read the press release