Mulpleta FDA nod in hand, Shionogi must distinguish it from competitor Dova's similar drug

Red blood cells
Shionogi's thrombocytopenia drug Mulpleta is very similar to Dova's Doptelet in terms of safety, efficacy and dosing convenience. (Wikimedia Commons)

Shionogi has won an FDA nod for Mulpleta, which is designed to boost platelet count in chronic liver disease patients before surgery. The approval, however, comes just two months after Dova Pharmaceuticals’ rival treatment Doptelet became the first drug approved in the U.S. for the condition and as analysts see it, the competition will be fierce.

Now both thrombopoietin receptor agonists have been approved to treat thrombocytopenia, the race will come down to market access and pricing strategy, since their efficacy, safety and dosing schedule are very similar to each other, according to analysts.

Shionogi’s Mulpleta (lusutrombopag), already approved in Japan, has two clinical studies to prove its case. In those two trials, 78% or 65% of patients who got Mulpleta didn’t need platelet transfusion prior to their procedures, beating placebo’s 13% or 29%.

While the Shionogi drug’s clinical response rate was numerically lower compared to Dova’s, Leerink’s analyst Geoffrey Porges noted that Shionogi’s endpoint is a bit more stringent. Therefore, he figured the two drugs “do not appear differentiated in efficacy.”

Each drug has its own advantage when it comes to convenience of administration. Different from the complicated dosing schedule used in some clinical trials, Mulpleta’s final label states that it uses a fixed dose for seven days, longer than the standard five days required for Doptelet.

However, as Evercore ISI analysts Jon Miller and Umer Raffat noted in a Tuesday memo to investors, Mulpleta can start 8 to 14 days prior to the scheduled procedure, while the window for Doptelet is narrower at 10 to 13 days.

“Not a big difference, maybe, but the wider window for Shionogi might make it easier to schedule procedures. In addition, pts can start dosing closer to an already-scheduled date, which makes it easier to give drug if thrombocytopenia concerns come up late in the process,” wrote the Evercore analysts.

RELATED: Dova prepares for newly minted Doptelet launch, with Shionogi’s rival close behind

Since the two drugs’ profile are quite similar, both Leerink and Evercore teams think the pricing strategy will be a key factor that differentiates the two therapies.

Shionogi hasn’t made public its price or a launch timeline. Dova announced on May 31 the wholesale acquisition price for Doptelet is $9,000 for the 40-mg form and $13,500 for the 60-mg dose, both significantly above Leerink’s previous prediction of $6,000.

In a note that day, Porges expressed his concerns for the high price. “Over the next few months, this price will also stretch Dova’s capacity for co-pay assistance and temporary free goods as payers prepare and implement their coverage policies for this medicine. Even in this indication, it is hard to predict how payers will react to a pretreatment regimen whose cost is significantly higher, in many cases, than the procedure itself,” he wrote.

Doptelet is the first drug Dova has ever launched, which could be challenging for the company. To ensure a successful launch, Dova started reimbursement support programs and put in place an entire sales team with prior experience in liver diseases. Now, it’s up to Shionogi to match that infrastructure.