FDA approves Progenics’ Azedra
The Food and Drug Administration has approved Progenics Pharmaceuticals’ Azedra (iobenguane I 131) injection for intravenous use, the company announced Tuesday. The drug is indicated for the treatment of adults and adolescents age 12 years old and older with rare tumors of the adrenal gland — pheochromocytoma or paraganglioma — that cannot be surgically removed — unresectable — have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use, Progenics said.
“Many patients with these ultra-rare cancers can be treated with surgery or local therapies, but there are no effective systemic treatments for patients who experience tumor-related symptoms, such as high blood pressure,” said Richard Pazdur, FDA’s oncology center of excellence director and acting director of the office of hematology and oncology products in the FDA’s center for drug evaluation and research.
“Patients will now have an approved therapy that has been shown to decrease the need for blood pressure medication and reduce tumor size in some patients.”
Pheochromocytomas are rare tumors of the adrenal glands, which produce such hormones as epinephrine and norepinephrine. Pheochromocytomas increase the production of these hormones, leading to hypertension andsuch symptoms as headaches, irritability, sweating, rapid heart rate, nausea, vomiting, weight loss, weakness, chest pain or anxiety. When this type of tumor occurs outside the adrenal gland, it is called a paraganglioma.
Sanofi’s first shipment of flu vaccines for 2018-2019 arrives
Sanofi Pasteur, the vaccine division of Sanofi, has shipped the first of its nearly 70 million flu vaccine doses to healthcare providers for the upcoming flu season, the company announced Monday. This year’s supply uses both egg-based and recombinant technologies, and includes increased production of Flublok quadrivalent vaccine and Fluzone high-dose vaccine, as well as continued supply of Fluzone quadrivalent (influenza vaccine).
“This past flu season was a stark reminder of how unpredictable flu can be. It is important to get vaccinated even if vaccine effectiveness is lower than we would like. Vaccination saves many lives, helps prevent numerous hospitalizations, and helps protect individuals and the public at large from severe, life-threatening complications,” Sanofi Pasteur associate vice president and regional medical head of North America David P. Greenberg said. “We are proud that in recent years we have introduced two vaccines proven to help prevent more flu than their respective standard-dose flu vaccine comparators in older adults. We are dedicated to continuing to find new ways to improve flu vaccines, particularly for those most impacted every year.”
Fluzone high-dose vaccine is the first and only flu vaccine shown to have superior efficacy compared with Fluzone vaccine in helping to protect against the flu in adults 65 years old and older (24.2% more effective), the company said. This vaccine also has been shown to be more effective at preventing flu-like illness and flu-associated hospitalizations, pneumonia and cardiorespiratory events in older adults, compared with standard-dose flu vaccine. Sanofi Pasteur expects that two-thirds of all adults 65 years old and older who will get a flu shot in the United States will receive Fluzone high-dose vaccine.
Flublok quadrivalent vaccine is indicated for adults 18 years old and older, and is proven to help prevent more cases of flu in people 50 years old and older compared with standard-dose quadrivalent inactivated flu vaccine (30% to 43% more protection). The vaccine is the only recombinant protein-based flu vaccine approved by the Food and Drug Administration, uniquely providing an exact genetic match of hemagglutinin (HA) from each recommended vaccine virus. HA is the protein identified as key to stimulating immunity to the flu.
Fluzone quadrivalent vaccine helps protect against four flu strains — two A strains and two B strains — and was the first four-strain flu vaccine licensed for use in people 6 months old.
FDA approves Perseris for schizophrenia
Durect announced that the Food and Drug Administration has approved Indivior’s Perseris (risperidone), which was formerly known as RBP-7000.
Perseris is the first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults, the company said.
“We are pleased to see Perseris receive FDA approval as an innovative treatment option for patients suffering from the very difficult medical condition of schizophrenia,” Durect president and CEO Jim Brown said.
On Sept. 26, 2017, Durect entered into a patent purchase agreement whereby Durect has assigned to Indivior U.K., an affiliate of Indivior PLC, certain patents that may provide further intellectual property protection for Perseris.