FDA Update: March 2018

Mar 8, 2018
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Express Scripts’ Emerging Therapeutics team features several of the important actions taken by the U.S. Food and Drug Administration (FDA), last month:

Symfi Lo and Cimduo Approved to Treat HIV-1

Mylan’s two new HIV drugs, Symfi Lo™ (efavirenz /lamivudine /tenofovir disoproxil fumarate) tablets and Cimduo™ (lamivudine /tenofovir disoproxil fumarate) tablets were approved by the FDA on Feb. 5, 2018. They are indicated to treat children weighing at least 35Kg (about 77 pounds), and adults who have HIV-1 infections. Symfi Lo, expected to be launched within the next few weeks, combines a lowered dose of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with two nucleoside reverse transcriptase inhibitors (NRTIs) as a once-daily, stand-alone treatment. Cimduo, to be introduced in the second quarter of 2018, will be used along with other antiretroviral drugs. Although exact pricing has not yet been announced, Mylan’s press release indicates that each will offer “significant discounts to the price of competing products”. Although both are similar to existing HIV medications, neither is interchangeable with any other drug. Prescribing information for Symfi Lo is available here. Cimduo’s can be found here.

Biktarvy Approved to Treat HIV

On Feb. 7, 2018, the FDA approved Gilead Sciences’ Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide), which is abbreviated as BIC/FTC/TAF. A once daily treatment for adults who have HIV-1 infections, it combines bictegravir, a new integrase strand transfer inhibitor (INSTI), with the NRTIs that are marketed together as Descovy®. Biktarvy is indicated to treat patients who have not yet been treated with antiretrovirals and patients who have had suppressed viral loads for at least three months on a previous HIV drug regimen. However, eligible patients must not have failed prior treatment or developed resistance to any of its components. It has a boxed warning for patients who have both HIV and hepatitis B because hepatitis B may re-emerge when Biktarvy treatment is stopped. Prescribing information is available here.

Generic to Syprine Available

Also on Feb. 7, 2018, Teva’s AB-rated generic to Valeant’s Syprine® (trientine) 250mg capsules received FDA approval. Syprine is a chelating agent used to treat Wilson's disease in patients who cannot take another medication known as penicillamine. Wilson's disease is a rare condition that causes the body to store too much copper. High levels of copper in the body can cause life-threatening organ damage. Syprine was included on FDA’s recently published “off-patent, off-exclusivity” list of brand drugs that do not have approved generics available. At the same time, the FDA implemented a new policy to expedite the review of generic applications when competition is limited. According to IQVIA (formerly QuintilesIMS), U.S. sales of Syprine tablets amounted to $155 million for calendar year 2017. Shipments of the generic already have begun.

Symdeko Approved to Treat Cystic Fibrosis

Symdeko™ (tezacaftor/ivacaftor and ivacaftor - Vertex) was approved by the FDA on Feb. 12, 2018. It is indicated to treat patients with cystic fibrosis (CF) who are at least 12 years old and who are either homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. FDA-approved CF mutation testing will be used to verify the patient’s genotype. Recommended daily dosing is one Symdeko tablet in the morning and one Kalydeco® (ivacaftor 150mg) tablet about 12 hours later; the two drugs will be packaged together. Vertex launched Symdeko at a wholesale acquisition cost (WAC) of $22,400 per 28-day package. Complete prescribing information is available here.

Erleada Approved for Prostate Cancer

Under its Priority Review program, the FDA approved Erleada™ (apalutamide) tablets on Feb. 14, 2018. A next-generation androgen receptor inhibitor, it is the first drug indicated to treat non-metastatic castration-resistant prostate cancer. Recommended dosing is four tablets (totaling 240mg) once a day. A gonadotropin-releasing hormone (GnRH) analog, such as Zoladex® (goserelin) implants, also should be used for patients who have not had a bilateral orchiectomy (surgical castration). List price is expected to be almost $11,000 per month. Janssen has not yet announced a launch date. Prescribing information for Erleada is available here.

Osmolex ER Approved

On Feb. 16, 2018, the FDA approved Osmotic Pharmaceutical’s Osmolex ER™ (amantadine) tablets, which contain both immediate-release and extended-release forms of the drug. It is indicated to treat adults who have Parkinson’s disease and also to relieve extrapyramidal side effects associated with the use of other drugs. Extrapyramidal symptoms include muscle spasms, restlessness, rigidity, trembling and slowed or jerky movements. Recommended dosing is 129mg each morning, which can be increased gradually to 322mg daily, if needed. Tablets will be available in 129mg, 193mg and 258mg strengths, which are not interchangeable with any other amantadine product. Osmotic has not yet announced launch or pricing plans. Legal actions brought by the manufacturer of another extended-release amantadine product may delay the introduction of Osmolex ER. Its prescribing information can be found here.

Generics Released for Solodyn 65mg and115mg

Under the terms of a settlement agreement, Teva Pharmaceutical Industries, Inc. launched generics for Solodyn® (minocycline - Medicis) extended-release tablets in 65mg and 115mg strengths on Feb. 20, 2018. It treats patients at least 12 years old who have moderate-to-severe acne. Teva will have 180 days of exclusivity before other generics can launch in the U.S. Also on Feb. 20, 2018, Impax announced the launch of its authorized generic version of Solodyn tablets in the same two strengths. According to IQVIA (formerly QuintilesIMS), U.S. sales for Solodyn 65mg and 115mg amounted to $148 million during 2017.

Apadaz Approved to Treat Acute Pain

KemPharm’s Apadaz™ (benzhydrocodone/acetaminophen) tablets was approved by the FDA on Feb. 23, 2018. It is an immediate-release opioid/acetaminophen combination product indicated for treating intense, acute pain that has not responded to other therapies. The recommended dose is one or two tablets every four to six hours as needed. No more than 12 tablets should be taken in any 24-hour period and treatment should last no longer than two weeks. The benzhydrocodone component is a prodrug that is not activated until it is exposed to gastrointestinal (GI) enzymes. Crushing it to inhale, inject or smoke will not produce the euphoria associated with misuse of other immediate-release opioids. However, it still can be abused by swallowing. Therefore, the FDA does not consider it to be abuse deterrent and it cannot claim to be in its labeling. The U.S. Drug Enforcement Administration (DEA) will schedule Apadaz as a C-II controlled substance, meaning that it has a high possibility for abuse. All opioids, including Apadaz, have several boxed warnings, including risks for abuse, addiction, overdose and respiratory depression. They caution about neonatal withdrawal syndrome for babies born to women who used opioids while pregnant, as well. Apadaz will be dispensed with a Medication Guide and under a Risk Evaluation and Mitigation Strategy (REMS). Although KemPharm has not yet announced its launch or pricing plans, it has indicated that it is open to innovative distribution arrangements. The cost of Apadaz is expected to be close to those of comparable generics. For full prescribing information, please click here.

FDA Approval for ZTlido

Sorrento Therapeutics announced on Feb. 28, 2018, that its subsidiary, Scilex Pharmaceuticals, has received FDA approval for ZTlido™ (lidocaine topical system) 1.8%. It is indicated to treat post-herpetic neuralgia (PHN), which is pain that continues after a case of shingles. Because it uses a different type of patch design, ZTlido is bioequivalent to currently available lidocaine patches, such as Lidoderm® (lidocaine) Patch 5%. It has a unique adhesive, as well, which provides more consistent skin contact. Some clinical trial patients developed mild, temporary blistering, burning, irritation, itching, redness, swelling or other topical side effects where it was applied. A launch is expected before the end of 2018, but prescribing and pricing information have not been released.

Author Bio

Lab Staff
comments powered by Disqus