Just a month after picking an accelerated review by U.S. regulators for its new blockbuster drug Hemlibra, the Swiss drugmaker Roche has now reported new data from two clinical trials that state the drug effectively cut down the bleeding episodes on patients with Hemophilia A for whom blood does not clot due to their genetic disorder.
Roche bets big on its new drug Hemlibra and anticipates it to be a huge revenue driver. Hemlibra is anticipated to make up for the declining revenue for the drugs that are out of patent, mainly its oncology drugs. These drugs are even facing competition from cheaper biosimilar. With hemlibra, Roche aims at boosting its hematology franchise.
This blockbuster drug Hemlibra had its share of controversy too. A couple of months back, it was reported that nearly five hemophilia patients who took the new drug Hemlibra passed away. This news made the drugmaker’s shares to nosedive. But Roche was quick to steer away from the controversy by stating the drug was not the reason for those deaths.
Roche bets big on its new drug Hemlibra and anticipates it to be a huge revenue driver. Hemlibra is anticipated to make up for the declining revenue for the drugs that are out of patent.
Last year, the U.S. regulators approved the drug for hemophilia A patients who had developed inhibitors to factor VIII therapy. This comprises of a very small group. But the latest two trials included patients without the factor VIII inhibitors. This latest study widens the use of the drug, that won itself a green signal in Europe this year.
Now the company is aiming to get the nod from the European regulators and FDA to use Hemlibra in patients with and without inhibitors.
This new finding is a major threat to Shire (SHPG) hemophilia franchise. This will soon be Takeda’s problem as Shire is being acquired by Takeda.
Roche eyes a large new market with this new drug and Jefferies analysts predict that by 2025 the drug would generate sales of $5 billion.
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