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Flexion recently announced the FDA approval of Zilretta for OA knee pain. Zilretta’s US sales will accelerate when the product’s label includes repeat administration – Pharmavitae Analytics predicts that Flexion’s ongoing Phase III safety trial will clear the way for repeat intra-articular administration in 2019. Flexion will search externally to replenish and grow its clinical pipeline – Buoyed by confidence in Zilretta’s future revenue, and with one investigational drug in preclinical development for OA and no clinical-stage candidates, Flexion will aggressively seek in-licensing opportunities.
Pharmavitae Analytics forecasts that Zilretta (triamcinolone acetonide extended-release injectable suspension), the only US Food and Drug Administration (FDA)-approved, extended-release, intra-articular treatment for osteoarthritis (OA) knee pain, will reach peak sales of $768m in the US (see Figure 1). Pharmavitae Analytics expects that Zilretta will experience strong market penetration among OA knee pain patients currently receiving intra-articular corticosteroid injection treatment. The drug will also experience high market uptake by patients with both OA knee pain and type 2 diabetes who cannot receive immediate-release corticosteroid treatment due to potential blood glucose disruption. Pharmavitae Analytics additionally anticipates that Zilretta’s revenue will receive a boost when the product’s label is updated to include a repeat administration indication in Q2 2019.
On 6 October 2017, Flexion Therapeutics announced that the FDA had approved Zilretta as an intra-articular injection for OA knee pain (Flexion, 2017a). Zilretta, which is not currently intended for repeat administration (Flexion, 2017a), was approved based on pivotal Phase III data demonstrating that a single administration of the corticosteroid achieved significant pain relief compared with placebo at 12 weeks (Flexion, 2016; 2017a). The product’s label also includes results from a Phase II study in type 2 diabetes patients, which suggest that Zilretta avoids the significant rise in blood glucose observed with immediate-release corticosteroid treatment (Flexion, 2017a; 2017b). Flexion expects that Zilretta will be available in the US by the end of October 2017 (Flexion, 2017a).
Pharmavitae Analytics forecasts that Zilretta will reach peak sales of $768m in the US, with a label update to include repeat administration anticipated in Q2 2019. Flexion expects topline results from an ongoing open-label, Phase III trial evaluating the safety of repeat administration of Zilretta for OA knee pain in Q3 2018 (Flexion, 2017c; 2017d), and Pharmavitae Analytics anticipates that the placebo-like safety of Zilretta that was demonstrated in the pivotal Phase III study (Flexion, 2016) will translate into long-term safety, as evidenced in the Phase III repeat administration trial.
Lack of direct competition in the medium term – Zilretta will successfully compete for a share of the OA knee pain market, despite carrying a significantly higher price than the generic corticosteroid intra-articular injection competition, due to it being the only extended-release intra-articular injection approved by the FDA for OA knee pain in the US. Zilretta will also provide an attractive option for patients with both OA knee pain and type 2 diabetes, representing 20% of the OA knee pain population in the US (Flexion, 2017c), based on Phase II results suggesting that the drug avoids the blood glucose spike associated with immediate-release corticosteroid treatment in these patients (Flexion, 2017b).
Revenue growth – Pharmavitae Analytics forecasts that Zilretta’s label will be updated to include a repeat administration indication for OA knee pain in Q2 2019, based on topline safety data from the ongoing, open-label Phase III trial expected in Q3 2018 (Flexion, 2017c; 2017d), providing a boost in US sales.