A Powerful First-In- Class Pcab for the Treatment of Erosive Gerd and Relief of Associated Heartburn
• VOQUEZNA, the first and only FDA-approved potassium-competitive acid blocker (PCAB), is now available through major retail pharmacies and BlinkRx, an end-to-end digital fulfillment channel
• VOQUEZNA tablets in 30-count bottles are now commercially available for the healing and maintenance of healing of all severities of Erosive GERD, and relief of heartburn associated with Erosive GERD1
FLORHAM PARK, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) – Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the U.S. commercial availability of VOQUEZNA® (vonoprazan). VOQUEZNA is now available for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), and the relief of heartburn associated with Erosive GERD.1 As the first and only approved potassium-competitive acid blocker (PCAB) in the U.S., this milestone brings the power of a new class of acid suppression treatment to a disease with high unmet need.
“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals. “For over three decades, there has been no major innovation in this category. We are excited to introduce VOQUEZNA to patients and healthcare providers, as it has been shown to provide rapid, potent, and durable acid suppression and has the power to help heal Erosive GERD for patients seeking a new and effective treatment option.”
The U.S. Food and Drug Administration (FDA) recently approved VOQUEZNA for the healing of all severities (grades) of Erosive GERD, maintenance of healing of all severities of Erosive GERD, and relief of heartburn associated with Erosive GERD in adults.1 Its novel mechanism of action (MOA) provides rapid, potent, and durable acid suppression in a way that is distinct from other prescription and over-the-counter medications.2 Additionally,VOQUEZNA does not have the burden of mealtime dosing, whereas most PPIs must always be taken with food.1
In a Phase 3, randomized clinical study, VOQUEZNA 20 mg met the primary endpoint of non-inferiority for complete healing by Week 8 in patients with all severities of Erosive GERD, demonstrating a strong healing rate of 93% compared to 85% for lansoprazole 30 mg, with superior rates of healing demonstrated in a secondary endpoint in patients with moderate- to-severe disease at Week 2 compared to lansoprazole (70% for VOQUEZNA 20 mg and 53% for lansoprazole 30 mg). In the maintenance phase of the study, VOQUEZNA 10 mg was superior to lansoprazole 15 mg in maintaining healing at six months in all randomized patients (79% for VOQUEZNA 10 mg, compared to 72% for lansoprazole 15 mg).
The most common side effects of VOQUEZNA for the treatment of Erosive GERD include stomach inflammation, diarrhea, stomach bloating, stomach pain, nausea, indigestion, high blood pressure, and urinary tract infection.
“Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn. When not properly treated, Erosive GERD can lead to complications such as scarring, narrowing of the esophagus, and bleeding,4” said Colin Howden, M.D., ProfessorEmeritus, University of Tennessee College of Medicine. “With many patients unsatisfied with their current therapy,5 the introduction of VOQUEZNA provides healthcare providers and patients with an important new treatment option that offers a novel mechanism of action and has demonstrated superiority in comparison to a standard-of-care PPI across several clinically meaningful endpoints.2”
Prescriptions for VOQUEZNA may be filled at major retail pharmacies and through BlinkRx, an end-to-end digital fulfillment channel. Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance. For more information, please visit www.voquezna.com/savings.
In addition, VOQUEZNA® TRIPLE PAK®(vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules), two treatment regimens for adults with H. pylori infection, are expected to be commercially available in mid-December 2023. VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK each contain 14-days of VOQUEZNA-based treatment co-packaged with antibiotics in convenient blister packs.
VOQUEZNA is marketed exclusively by Phathom Pharmaceuticals, Inc. Please visit www.voquezna.com to learn more about VOQUEZNA.
INDICATION AND IMPORTANT SAFETY INFORMATION
What is VOQUEZNA?
VOQUEZNA® (vonoprazan) is a prescription medicine used in adults:
• for 8 weeks to heal acid-related damage to
the lining of the esophagus (called Erosive Esophagitis or Erosive Acid Reflux) and for relief of heartburn related to Erosive Acid Reflux.
• for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.
It is not known if VOQUEZNA is safe and effective in children.
Do not take VOQUEZNA if you:
• are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching and swelling of your face, lips, tongue, or throat.
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• are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY , CABENUV A) used to treat HIV-1 (Human Immunodeficiency Virus).
Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you:
• have low magnesium, calcium, or potassium
in your blood, or you are taking a medicine to
increase urine (diuretic).
• have kidney or liver problems.
• are pregnant, think you may be pregnant, or
plan to become pregnant. It is not known if
VOQUEZNA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or
breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
VOQUEZNA may affect how other medicines work, and other medicines may affect how VOQUEZNA works. Especially tell your healthcare provider if you take medicine that contains rilpivirine (EDURANT, COMPLERA,JULUCA, ODEFSEY, CABENUVA).
What are the possible side effects of VOQUEZNA?
VOQUEZNA may cause serious side effects including:
A type of kidney problem (acute tubulointerstitial nephritis): Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you notice blood in your urine.
Diarrhea caused by an infection (Clostridioides difficile) in your intestines: Call your healthcare provider right away if you have watery stools,
stomach pain, and fever that does not go away. Bone fractures (hip, wrist, or spine): Bone
fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare provider if you have a bone fracture, especially in the hip, wrist, or spine.
Severe skin reactions: VOQUEZNA can cause rare, but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
• Skin rash which may have blistering, peeling, or bleeding on any part of your skin.
• You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. • If you experience any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away. These symptoms may be
the first sign of a severe skin reaction.
Low vitamin B-12 levels: VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the arms or legs, muscleweakness, pale skin, feeling tired, or mood changes. Talk with your healthcare provider about the risk of low vitamin B12 levels if you
have been on VOQUEZNA for a long time. Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of hands, feet, or voice.
Stomach growths (fundic gland polyps): A certain type of stomach growth called fundic gland polyps may happen in people who take another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long time. Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.
The most common side effects of VOQUEZNA for treatment of Erosive Acid Reflux include: • stomach inflammation
• diarrhea
• stomach bloating
• stomach pain
• nausea
• indigestion
• high blood pressure
• urinary tract infection
These are not all the possible side effects of VOQUEZNA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.