<p>British drugmaker GSK Plc said on Friday the US Food and Drug Administration had approved its oral therapy to treat anemia in patients with a type of bone marrow cancer called myelofibrosis.</p>.<p>The approval comes after the health regulator in July delayed its decision to review additional data.</p>.<p>The therapy, momelotinib, has been approved for patients "regardless of prior myelofibrosis therapy", according to GSK's statement on the FDA's approval.</p>.US FDA authorises updated Covid vaccines.<p>While GSK's therapy, branded as Ojjaara, also belongs to the same class of treatments, it additionally helps bring down the levels of a protein called hepcidin, which regulates how the body uses iron.</p>.<p>Myelofibrosis is associated with high levels of hepcidin and disrupts the body's production of blood cells, often causing severe anemia, or a deficiency of red blood cells. People with myelofibrosis-triggered anemia rely on periodic blood transfusions to improve their red blood cell count.</p>.<p>It affects less than 50,000 patients in the US, according to government data.</p>.<p>Friday's approval is based on data from a late-stage study that showed the therapy was successful in reducing disease symptoms and cut patients' dependence on blood transfusions, compared with patients who received another anemia treatment called danazol.</p>.<p>Morningstar analyst Damien Conover estimated the therapy would gain close to 50 per cent of the second-line myelofibrosis market and projected annual peak sales of close to 500 million pounds ($627.45 million).</p>.<p>"(Momelotinib) helps drive long-term growth for GSK as the patent protection extends beyond 2033 in key markets," Conover said ahead of the approval.</p>.<p>In an effort to boost its cancer business, GSK added momelotinib to its pipeline through a $1.9 billion buyout of cancer drug developer Sierra Oncology last year.</p>.<p>GSK's oncology business, which made up 2 per cent of its total sales in 2022, suffered trial setbacks on two cancer compounds that were touted as potential blockbusters last year.</p>.<p>Sierra had earlier acquired momelotinib from Gilead Sciences in 2018 for an upfront payment of $3 million, with up to $195 million in milestone payments.</p>.<p><em>($1 = 0.7969 pounds)</em> </p>
<p>British drugmaker GSK Plc said on Friday the US Food and Drug Administration had approved its oral therapy to treat anemia in patients with a type of bone marrow cancer called myelofibrosis.</p>.<p>The approval comes after the health regulator in July delayed its decision to review additional data.</p>.<p>The therapy, momelotinib, has been approved for patients "regardless of prior myelofibrosis therapy", according to GSK's statement on the FDA's approval.</p>.US FDA authorises updated Covid vaccines.<p>While GSK's therapy, branded as Ojjaara, also belongs to the same class of treatments, it additionally helps bring down the levels of a protein called hepcidin, which regulates how the body uses iron.</p>.<p>Myelofibrosis is associated with high levels of hepcidin and disrupts the body's production of blood cells, often causing severe anemia, or a deficiency of red blood cells. People with myelofibrosis-triggered anemia rely on periodic blood transfusions to improve their red blood cell count.</p>.<p>It affects less than 50,000 patients in the US, according to government data.</p>.<p>Friday's approval is based on data from a late-stage study that showed the therapy was successful in reducing disease symptoms and cut patients' dependence on blood transfusions, compared with patients who received another anemia treatment called danazol.</p>.<p>Morningstar analyst Damien Conover estimated the therapy would gain close to 50 per cent of the second-line myelofibrosis market and projected annual peak sales of close to 500 million pounds ($627.45 million).</p>.<p>"(Momelotinib) helps drive long-term growth for GSK as the patent protection extends beyond 2033 in key markets," Conover said ahead of the approval.</p>.<p>In an effort to boost its cancer business, GSK added momelotinib to its pipeline through a $1.9 billion buyout of cancer drug developer Sierra Oncology last year.</p>.<p>GSK's oncology business, which made up 2 per cent of its total sales in 2022, suffered trial setbacks on two cancer compounds that were touted as potential blockbusters last year.</p>.<p>Sierra had earlier acquired momelotinib from Gilead Sciences in 2018 for an upfront payment of $3 million, with up to $195 million in milestone payments.</p>.<p><em>($1 = 0.7969 pounds)</em> </p>