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FDA’s year-end approvals take annual tally to 46

Rhopressa and Steglatro were among the final medicines licensed last year


Green lights for Aerie Pharma and Merck & Co/Pfizer have taken the number of new drugs approved by the FDA in 2017 to 46, a big increase on the prior year and just above the record 45 approvals in 2015.

The traditional late flurry of approvals was a bit smaller this year, but included Aerie Pharma’s Rhopressa (netarsudil), a once-daily drug for open-angle glaucoma and ocular hypertension that got the go-ahead two months ahead of schedule and has been billed by the company as a potential blockbuster.

Aerie chief executive Vicente Anido said the approval was the company’s “single greatest achievement” to date, adding that the company will be hiring 100 sales reps to in the first quarter of 2018 in anticipation of a second-quarter launch. Next year, it hopes to add a second glaucoma drug to its portfolio with Roclatan (netarsudil/latanoprost) which is scheduled for filing in the coming months.

Merck and Pfizer picked up an FDA approval for SGLT2 inhibitor Steglatro (ertugliflozin) and combinations Steglujan (ertugliflozin and sitagliptin) and Segluromet (ertugliflozin and metformin) for use in adults with type 2 diabetes mellitus.

Steglatro is the fourth-to-market drug in the fast-growing SGLT2 inhibitor class and it will have to try to penetrate the market in the face of tough competition from established drugs Johnson & Johnson’s first-to-market blockbuster Invokana (canagliflozin) - which brought in more than $1.2bn last year - fast-gaining rival Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim and AstraZeneca’s Farxiga (dapagliflozin) which is a big player in Europe.

Merck and Pfizer are hoping that Steglujan will benefit from piggy-backing on Merck’s Januvia - the top-selling DPP-4 inhibitor - backed by some strong clinical data for the combination which as yet is the only fixed-dose SGLT2/DPP-4 inhibitor pairing on the US market. Steglatro and Steglujan are due for launch this month, with Segluramet expected to be available in February.

The closing few days of 2017 also saw line extension approvals for Exelixis and Novartis. Exelixis got the nod from the US regulator for Cabometyx (cabozantinib) as a first-line treatment for advanced renal cell carcinoma, giving the drug a boost against rival Sutent (sunitinib) from Pfizer which it outperformed in a phase II pivotal trial.

Previously-untreated RCC is a much bigger population for the drug, and comes after an April 2016 approval as a second-line therapy for this type of cancer after VEGF-targeting therapy. Analysts at Leerink have suggested the new indication could catapult Exelixis’ cabozantinib franchise to $1bn in sales in 2025.

Meanwhile, Novartis got the go-ahead for new labelling for its chronic myeloid leukaemia (CML drug Tasigna (nilotinib. It has become the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to include data about attempting treatment discontinuation in adult patients with Philadelphia chromosome-positive CML.

Patients with early (chronic) phase CML who have been taking Tasigna for three years or more and whose leukaemia has responded to treatment, may be eligible to stop taking Tasigna, according to the FDA. Prior to this, patients faced “a lifetime of treatment to keep their leukaemia from growing or recurring”, said the FDA.

Article by
Phil Taylor

2nd January 2018

From: Regulatory



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