Pfizer gets FDA green light for Daurismo
The Food and Drug Administration gave its blessing to Pfizer’s Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, or LDAC, a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia, or AML in adults who are 75 years old or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy.
“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today’s approval gives healthcare providers another tool to use in the treatment of AML patients with various, unique needs,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy.”
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow.
The National Cancer Institute at the National Institutes of Health estimates that in 2018, approximately 19,520 people will be diagnosed with AML, and approximately 10,670 patients with AML will die of the disease. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities.
The FDA granted this application Priority Review designation.
Daurismo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
AllianceRx Walgreens Prime expands specialty drug offerings
Central specialty and home delivery pharmacy AllianceRx Walgreens Prime is expanding availability of specialty drugs for patients with certain rare, chronic and complex conditions. The newly available limited-distribution drugs treat such rare conditions as metastatic breast cancer, chronic liver disease, metastatic non-small cell lung cancer, and hereditary angioedema.
“In our ongoing support of patients with chronic, complex conditions and rare diseases, these additions make it easier for patients to get the medications they need,” AllianceRx Walgreens Prime CEO Joel Wright said. “While the FDA’s approval of these medications supports our purpose of providing hope and care for better tomorrows, access to medication is just part of our treatment approach. Our pharmacists use an integrated care management program to deliver comprehensive and collaborative care for patients throughout their care journey.”
AllianceRx Walgreens Prime patients now have access to the following specialty drugs:
- Doptelet (avatrombopag), which is used to treat thrombocytopenia, or low blood platelet count, in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Manufactured by Dova Pharmaceuticals, this is the first in its class approved by the Food and Drug Administration for this use;
- Galafold (migalastat), which is the first oral medicine for Fabry disease, a rare, progressive genetic disorder characterized by a defective gene that causes an enzyme deficiency and impacts the kidneys. Manufactured by Amicus Therapeutics, Galafold is the first new therapy approved to treat adult patients with Fabry disease and an amenable galatosidase alpha gene variant in more than 15 years;
- Revcovi (elapegademase-lvlr), manufactured by Leadiant Biosciences, treats adenosine deaminase severe combined immune deficiency, or ADA-SCID, affecting children and adults. ADA-SCID is caused by a deficiency in the ADA enzyme that is fatal if left untreated. Patients affected by ADA-SCID have compromised immune systems that leave them unprotected from infection-producing bacteria, viruses and fungi;
- Ruconest (C1 esterase inhibitor [recombinant]), distributed by Pharming Healthcare, is an intravenously infused medicine used to treat acute angioedema, or rapid swelling beneath the skin, attacks in adults and adolescents with hereditary angioedema;
- Talzenna (talazoparib), manufactured by Pfizer, is used to treat patients who have a certain type of breast cancer called human epidermal growth factor receptor 2, or HER2-negative, an abnormal inherited BRCA gene, and whose cancer has spread to other parts of the body, locally advanced or metastatic;
- Vizimpro (dacomitnib) treats non-small cell lung cancer that has spread to other parts of the body (metastatic). Also manufactured by Pfizer, Vizimpro is used as a first-line treatment if tumors have certain types of abnormal epidermal growth factor receptor genes; and
- Zavesca (miglustat) is used alone to treat adults with mild-to-moderate Type 1 Gaucher disease, a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials called lipids. Zavesca is used only in people who cannot be treated with enzyme replacement therapy.
NACDS’ Anderson provides state-level election results analysis
Aggressive engagement at the state level will remain a top priority of the National Association of Chain Drug Stores in 2019, in partnership with allied state associations and other key in-state partners. That’s according to NACDS president and CEO Steve Anderson in a recent memo, in which he provided the following overview of the state elections:
Eighty-seven of the 99 state legislative chambers were up for election with over 80% of the total state legislative seats in the country in play. The outcomes of the state elections indicate gains by Democrats. Preliminary results indicate that Democrats gained control of at least seven state legislative chambers, less than the average 12 chambers that change party hands in every two-year election cycle dating back to 1900.
These seven chambers include the Colorado Senate, Connecticut Senate (tied prior to the election), Maine Senate, Minnesota House, New Hampshire Senate and House, as well as the New York State Senate.
Party control of the Alaska House is pending the outcome of several races that are still too close to call and results are still being tabulated. Republicans retain majority control of 29 state legislatures while Democrats control 18 state legislatures.
Currently, Minnesota is the only state in the nation where the legislature is divided — the Senate remains in Republican control while the House flipped to the Democrats. According to the National Conference of State Legislatures, the last time that occurred nationally was in 1914. State legislative control is pending in Alaska as results are still being tabulated. Nebraska has a non-partisan, unicameral chamber.
Gubernatorial elections took place in 36 states in 2018. Democrats picked up seven governors’ offices, including Illinois, Kansas, Maine, Michigan, Nevada, New Mexico, and Wisconsin, while Republicans gained one in Alaska. The net effect is Republicans hold 27 of the 50 governorships next year while the Democrats hold 23.
Preparing for 2019 Republicans maintained their control over a majority of state governments with combined control of the state legislative chambers and the governorships in 21 states (down from 25) while Democrats will now control 14 state governments (up from eight). Thirteen states have divided control (down from 16). Nebraska is nonpartisan. Alaska is pending the outcome of the House races.
In Idaho, Nebraska, and Utah voters approved ballot initiatives to expand Medicaid coverage while Montana voters rejected a ballot measure to remove the sunset date for the current Medicaid expansion that was tied to a tobacco tax increase.
Earlier this year, Oregon voters approved a tax plan levied on Oregon’s largest hospitals and many health insurance policies by 2019. Funds will be spent on Oregonians’ health care.